Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
68
Countries
1
Sites
1
Type 2 diabetes mellitus
Key facts
- Sponsor
- Institut De Recherches Internationales Servier IRIS
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 7 Nov 2023 → 20 Dec 2023
- Decision date (initial)
- 2023-11-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Type 2 diabetes mellitus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10067585 | Type 2 diabetes mellitus | 100000004861 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Recherches Internationales Servier IRIS
- Sponsor organisation
- Institut De Recherches Internationales Servier IRIS
- Address
- 22 Route 128
- City
- Gif Sur Yvette
- Postcode
- 91190
- Country
- France
Scientific contact point
- Organisation
- Institut De Recherches Internationales Servier IRIS
- Contact name
- Valérie Brunet
Public contact point
- Organisation
- Institut De Recherches Internationales Servier IRIS
- Contact name
- Regulatory Affairs & Pharmacovigilance Management
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Ended | 68 | 1 |
| 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 |
|---|---|---|---|---|---|
| Portugal | 2023-11-07 | 2023-12-20 | 2023-11-07 | 2023-11-14 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-08 | Portugal | Acceptable 2023-10-31
|
2023-11-03 |