Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
10
Countries
1
Sites
2
Type 1 Diabetes
Key facts
- Sponsor
- Academisch Ziekenhuis Leiden
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 2 Dec 2024 → ongoing
- Decision date (initial)
- 2024-10-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Type 1 Diabetes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.0 | LLT | 10085412 | Immune-mediated diabetes | 100000004848 |
| 21.1 | LLT | 10012608 | Diabetes mellitus insulin-dependent | 10027433 |
| 20.0 | PT | 10012601 | Diabetes mellitus | 100000004861 |
| 20.0 | LLT | 10012609 | Diabetes mellitus juvenile onset | 10027433 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Academisch Ziekenhuis Leiden
- Sponsor organisation
- Academisch Ziekenhuis Leiden
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Academisch Ziekenhuis Leiden
- Contact name
- JJ Zwaginga
Public contact point
- Organisation
- Academisch Ziekenhuis Leiden
- Contact name
- JJ Zwaginga
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 10 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-12-02 | 2025-06-18 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-21 | Netherlands | Acceptable 2024-10-30
|
2024-10-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-29 | Netherlands | Acceptable 2025-05-12
|
2025-05-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-09 | Netherlands | Acceptable 2025-10-03
|
2025-10-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-08 | Netherlands | Acceptable 2026-03-24
|
2026-03-24 |