Overview
Sponsor-declared trial summary
Gestational diabetes
The primary objective is to evaluate the difference in 68Ga-exendin tracer accumulation in the pancreas of patients with and without a history of gestational diabetes by quantitative analysis of PET images.
Key facts
- Sponsor
- Radboud universitair medisch centrum Stichting
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Metabolism [G03]
- Decision date (initial)
- 2025-01-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520392-27-00
- EudraCT number
- 2016-000794-20
- ClinicalTrials.gov
- NCT03182296
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
The primary objective is to evaluate the difference in 68Ga-exendin
tracer accumulation in the pancreas of patients with and without a
history of gestational diabetes by quantitative analysis of PET images.
Secondary objectives 1
- To determine the correlation between 68Ga-exendin tracer accumulation and beta cell function of the subjects as assessed by oral glucose tolerance testing
Conditions and MedDRA coding
Gestational diabetes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Pregnancy with diagnosis of GDM, within the last 5 years
- No other previous pregnancies
- Complete resolution of GDM after delivery (HbAlc in normal range, fasting glucose < 1OO mg/dl for at least I year in the absence of active pharmacologic therapy or ongoing procedures)
- Signed informed consent
Exclusion criteria 8
- Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta@) or Dipeptidyl-Peptidase IV inhibitors
- Breast feeding
- Current pregnancy or the wish to become pregnant within 6 months
- Renal dysfunction (Calculated creatinine clearance below 40 ml/min)
- Liver disease defined as aspartate aminotransferase or alan¡ne aminotransferase level of more than three times the upper limit of normal range
- Age < 18 years
- incapacitated
- no signed informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The main parameter of the study is the quantitative assessment of pancreatic 68Ga-NODAGA-exendin-4 uptake women with and without a history of GDM by PET/CT.
Secondary endpoints 1
- The correlation between Ga-exendin tracer accumulation and beta cell function of the subjects
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
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 INJECTION/IV INFUSION
- Max daily dose
- 150 MBq megabecquerel(s)
- Max total dose
- 150 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 labelling with Ga68
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
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-520392-27-00 | 1.1 |
| Recruitment arrangements (for publication) | K1_blank_document_Recruitment_arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_women_with_GDM | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_women_without_GDM | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_blank_document_Summary_product_characteristics | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Netherlands | Acceptable 2025-01-13
|
2025-01-13 |