Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
114
Countries
1
Sites
1
Type 2 diabetes mellitus
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 21 Feb 2025 → 12 Jan 2026
- Decision date (initial)
- 2024-09-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508940-23-01
- WHO UTN
- U1111-1298-9340
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Type 2 diabetes mellitus
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 |
|---|---|---|---|
| Austria | Ended | 114 | 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 |
|---|---|---|---|---|---|
| Austria | 2024-11-18 | 2026-01-12 | 2024-11-20 | 2025-05-29 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-70887
- Halt date
- 2025-02-06
- Member states concerned
- Austria
- Publication date
- 2025-02-14
- Reason
- Study management related
- Explanation
- The temporary halt is reported as we have identified a typographical error in the protocol version 2.0, dated 14-Nov-2024 in exclusion criterion #20, where less-than (<) signs were used instead of greater-than (>) signs to specify QTcF interval prolongation. The intended criterion is to exclude participants with QTcF intervals exceeding 460 ms for females and 450 ms for males. The fact that this is a typographical error is supported by the inclusion criterion #5 “Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator”.
- Follow-up measures
- Upon identification of this typographical error on 05 Feb 2025, we paused the screening and recruitment on 06 Feb 2025 to evaluate the safety and well-being of the participants and to deliberate the actions required. Novo Nordisk monitors have performed source data verification of the QTcF intervals for all randomised participants (n=55) on 06 Feb 2025 and have concluded that no participants have been randomised with a QTcF interval over 460 ms for females or over 450 ms for males. Thereby, all participants have been included and randomised based on the intention of the exclusion criterion and the investigator and sponsor medical team have evaluated that there are no safety concerns for the randomised participants. Hence, the study is not halted for reasons of change of participants safety or in the benefit-risk balance.
The protocol has been updated to version 3.0 dated 12-Feb-2025 to correct the typographical error and we plan to restart recruitment as soon as the EC has acknowledged our request under MDR. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-10 | Austria | Acceptable 2024-09-09
|
2024-09-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-17 | Austria | Acceptable 2024-09-09
|
2024-10-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-23 | Austria | Acceptable 2024-09-09
|
2024-10-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-29 | Austria | Acceptable | 2025-03-17 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-08 | Austria | Acceptable 2025-07-07
|
2025-07-14 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-12 | Austria | Acceptable 2025-10-20
|
2025-10-20 |