Phase 1 study of Sublin novel sublingual insulin formulation in adults with T1D
What this study tests
A first-in-human phase 1 study in the Netherlands evaluating a novel sublingual (under-the-tongue) insulin formulation developed by Sublin B.V. in adult men with type 1 diabetes.
Editorial review: .
Registry checked: 2026-10-19. Registry’s own update: 2026-09-08.
Most recent recorded citation date: 2026-09-08. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adult male patients aged 18–64 years with type 1 diabetes mellitus. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted. Registry checked 19 October 2026 (EU CTIS 2025-521863-11-00 authorised 4 September 2026, EU trial start 7 September 2026, published 8 September 2026): ongoing in Enschede, Netherlands; planned n=19; estimated completion March 2027.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: European Union. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Phase 1 safety, tolerability, and pharmacokinetics/pharmacodynamics (full endpoint text deferred under CTIS Phase 1 rules)
The full picture
What the study asks
EUCT 2025-521863-11-00 is a phase 1 clinical study sponsored by Sublin B.V. and conducted at the Centre for Human Drug Research (Enschede, Netherlands) to test a novel sublingual insulin formulation in adults with type 1 diabetes.1
Who it involves
The public EU Clinical Trials Information System (CTIS) summary lists 19 planned adult male participants aged 18–64 years with type 1 diabetes mellitus.1
Design and timing
The trial was authorised in the Netherlands on 4 September 2026, recorded its actual EU start of trial on 7 September 2026, and was published on CTIS on 8 September 2026, with an estimated end date of 1 March 2027. Detailed product specifications and primary endpoint wording are deferred from public display under EU CTIS Category 1 (Phase 1) transparency deferral rules.1
Evidence and limits
No results are posted. Historically, mucosal, oral, and sublingual insulin formulations have faced high bioavailability variability; a small phase 1 pharmacokinetic/safety trial does not establish clinical mealtime efficacy.1
Sources
- [1]A Phase 1 Study to Investigate a Novel Sublingual Insulin Formulation in Patients With Type 1 Diabetes Mellitus (EUCT 2025-521863-11-00) · Trial registry · 2026-09-08 — EU CTIS record checked 19 October 2026: Authorised 4 September 2026; EU start of trial 7 September 2026 at Centre for Human Drug Research (Enschede, Netherlands); planned n=19; full product and endpoint text deferred under Category 1 Phase 1 transparency rules.
EU Clinical Trials Information System (CTIS). EUCT 2025-521863-11-00. Authorised 4 September 2026; trial start 7 September 2026; published 8 September 2026; checked 19 October 2026.