Clinical trial • Phase IV • Endocrinology
EXENATIDE for Type 1 diabetes mellitus
Phase IV trial of EXENATIDE for Type 1 diabetes mellitus.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 1 diabetes mellitus
- Trial Stage
- Phase IV
- Drug Modality
- Peptide/protein/enzyme | Radiopharmaceutical | Small molecule
Key dates
- Initial CTIS Submission Date
- 07-10-2024
- First CTIS Authorization Date
- 30-01-2025
Trial design
Randomised, verapamil versus placebo; verapamil (oral) -- max daily dose reported 360 mg (dosing schedule not specified in record); placebo (details not specified).-controlled Phase IV trial across 4 sites in Austria, France.
- Randomised
- Yes
- Comparator
- Verapamil versus placebo; Verapamil (oral) -- max daily dose reported 360 mg (dosing schedule not specified in record); placebo (details not specified).
- Target Sample Size
- 10
- Trial Duration For Participant
- 365
Eligibility
Recruits 10 No vulnerable populations selected. Participants must be adults (Age ≥18 years) and provide written informed consent; no assent procedures are indicated..
- Pregnancy Exclusion
- Pregnancy or the wish to become pregnant within 2 months after second PET/CT scan.
- Vulnerable Population
- No vulnerable populations selected. Participants must be adults (Age ≥18 years) and provide written informed consent; no assent procedures are indicated.
Inclusion criteria
- {"criterion_text":"- Are included in the VER-A-T1D trial, but have not started treatment/placebo.\n- have given written informed consent.\n- Age ≥18 years at consent"}
Exclusion criteria
- {"criterion_text":"- 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.\n- Renal disease defined as MDRD < 40 ml/min/1.73m²\n- Pregnancy or the wish to become pregnant within 2 months after second PET/CT scan."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The total pancreatic uptake of 68Ga-NODAGA-exendin for determination of beta cell mass at the point of inclusion and after 12 months.","definition_or_measurement_approach":"Measurement of pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT to determine beta cell mass at inclusion and after 12 months."}
Secondary endpoints
- {"endpoint_text":"- Changes in 68Ga-NODAGA-exendin pancreas uptake in realtion to changes in C-peptide measurements.","definition_or_measurement_approach":"Comparison of changes in pancreatic 68Ga-NODAGA-exendin uptake (PET) with changes in C-peptide measurements."}
- {"endpoint_text":"- Changes in 68Ga-NODAGA-exendin pancreas uptake in relation to changes in proinsulin/preproinsulin measurements.","definition_or_measurement_approach":"Comparison of changes in pancreatic 68Ga-NODAGA-exendin uptake (PET) with changes in proinsulin/preproinsulin measurements."}
- {"endpoint_text":"- Differences in 68Ga-NODAGA-exendin uptake between individuals and between the two timepoints of imaging intra-individually","definition_or_measurement_approach":"Quantification of inter-individual differences and intra-individual differences between the two imaging time points in 68Ga-NODAGA-exendin uptake for future sample size calculations."}
Recruitment
- Planned Sample Size
- 10
- Recruitment Window Months
- 51
- Consent Approach
- Written informed consent is required from each participant ('have given written informed consent.'). Participants must be ≥18 years. Subject information and informed consent form documents are listed for Austria (German) and France (French).
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 20
Austria
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 30-01-2025
- Processing Time Days
- 92
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- University Hospital Graz
- Department Name
- Internal Medicine
- Principal Investigator Name
- Thomas Pieber
- Principal Investigator Email
- thomas.pieber@medunigraz.at
- Contact Person Name
- Thomas Pieber
- Contact Person Email
- thomas.pieber@medunigraz.at
- Site Name
- Medical University Of Vienna
- Department Name
- Nuclear Medicine
- Principal Investigator Name
- Marcus Hacker
- Principal Investigator Email
- marcus.hacker@meduniwien.ac.at
- Contact Person Name
- Marcus Hacker
- Contact Person Email
- marcus.hacker@meduniwien.ac.at
France
- Earliest CTIS Part Ii Submission Date
- 03-12-2024
- Latest Decision Or Authorization Date
- 30-01-2025
- Processing Time Days
- 58
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Nuclear Medicine
- Principal Investigator Name
- Jean-Noel Talbot
- Principal Investigator Email
- jean-noel.talbot@aphp.fr
- Contact Person Name
- Jean-Noel Talbot
- Contact Person Email
- jean-noel.talbot@aphp.fr
- Site Name
- Hopital Tenon
- Department Name
- Nuclear Medicine
- Principal Investigator Name
- Cyrielle Aveline
- Principal Investigator Email
- cyrielle.aveline@aphp.fr
- Contact Person Name
- Cyrielle Aveline
- Contact Person Email
- cyrielle.aveline@aphp.fr
Sponsor
Primary sponsor
- Full Name
- Radboud universitair medisch centrum Stichting
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- EXENATIDE
- Active Substance
- EXENATIDE
- Modality
- Peptide/protein/enzyme | Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS BOLUS USE
- Route
- Intravenous bolus
- Maximum Dose
- 100 MBq
- Investigational Product Name
- VERAPAMIL
- Active Substance
- VERAPAMIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Frequency
- up to 360 mg/day
- Maximum Dose
- 360 mg
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