Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
120
Countries
1
Sites
1
Type 2 Diabetes
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 7 Aug 2023 → 18 Apr 2024
- Decision date (initial)
- 2023-07-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-503949-65-00
- WHO UTN
- U1111-1281-4819
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Type 2 Diabetes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10045242 | Type II diabetes mellitus | 10027433 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novo Nordisk A/S
- Sponsor organisation
- Novo Nordisk A/S
- Address
- Novo Alle 1
- City
- Bagsvaerd
- Postcode
- 2880
- Country
- Denmark
Scientific contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission Hub
Public contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission Hub
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 120 | 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 |
|---|---|---|---|---|---|
| Germany | 2023-08-07 | 2024-04-18 | 2023-08-12 | 2024-03-01 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-29 | Germany | Acceptable 2023-07-11
|
2023-07-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-18 | Germany | Acceptable 2023-10-11
|
2023-10-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-17 | Germany | Acceptable 2023-12-11
|
2023-12-12 |