Clinical trial • Phase III • Endocrinology
semaglutide for Type 1 diabetes
Phase III trial of semaglutide for Type 1 diabetes. 96 participants.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 1 diabetes
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme|Other
Key dates
- Initial CTIS Submission Date
- 04-04-2025
- First CTIS Authorization Date
- 28-05-2025
Trial design
Phase III trial across 1 site in Germany.
- Target Sample Size
- 96
Eligibility
Recruits 96 Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on specific vulnerable groups, consent or assent handling are provided in the CTIS record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on specific vulnerable groups, consent or assent handling are provided in the CTIS record.
Recruitment
- Planned Sample Size
- 96
- Recruitment Window Months
- 14
- Consent Approach
- Not specified in CTIS record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 96
Germany
- Earliest CTIS Part Ii Submission Date
- 16-05-2025
- Latest Decision Or Authorization Date
- 28-10-2025
- Processing Time Days
- 165
- Number Of Sites
- 1
- Number Of Participants
- 96
Sites
- Site Name
- PROFIL Institut fuer Stoffwechselforschung GmbH
- Contact Person Name
- Grit Andersen
- Contact Person Email
- grit.andersen@profil.com
Sponsor
Primary sponsor
- Full Name
- Novo Nordisk A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Investigational products
- Investigational Product Name
- NNC0194-0499
- Modality
- Other
- Investigational Product Name
- semaglutide
- Active Substance
- semaglutide
- Modality
- Peptide/protein/enzyme
- Combination Treatment
- Yes
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