NNC0363-1063: glucose-clamp study in type 1 diabetes
What this study tests
A second, smaller Novo Nordisk Phase 1 of the same glucose-sensitive insulin, run only in people with type 1 diabetes and built around a glucose clamp. The primary endpoint — area under the glucose infusion rate curve at steady state — is the standard way to measure how much glucose a body needs to be fed to hold blood sugar steady, which is the direct measure of an insulin's potency. Completed May 2026; no results posted.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-06-05.
Most recent recorded citation date: 2025-12-16. 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?
- Adults 18-64 with type 1 diabetes. No healthy volunteers in this study. 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. The registry records completion on 8 May 2026 with 36 participants. Glucose-clamp measurements can characterize insulin action under controlled conditions; completion alone does not establish glucose responsiveness or everyday clinical benefit.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
- Area under the glucose infusion rate-time curve at steady state (AUC,GIR,SS)
The full picture
The smaller of Novo Nordisk's two completed Phase 1 studies of NNC0363-1063, and the one run only in people with type 1 diabetes.
Why the endpoint matters. In a glucose clamp, blood glucose is held at a fixed level and the amount of glucose that has to be infused to keep it there is measured. That infusion rate is the insulin's effect, measured directly rather than inferred. Running the clamp at steady state, in people with T1D, is the cleanest available test of two things a glucose-responsive insulin has to prove: that it is potent enough to be a real insulin, and that its potency actually changes with glucose.
Why its silence is the story. This is the study design most capable of producing the human glucose-response curve nobody has published. It completed in May 2026. As of August 2026 no results are posted. Until they are, the glucose-responsive insulin class has completed clamp work in people with T1D and disclosed none of it — which is weaker evidence than it sounds, and stronger than "preclinical".
Sources
- [1]A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes · Trial registry · 2025-12-16 — Phase 1, n=36, started 16 Dec 2025, completed 8 May 2026. Single site (Germany). Primary endpoint AUC,GIR,SS. No results posted as of Aug 2026.