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type1.science
Phase 1CompletedNCT07305805

NNC0363-1063: glucose-clamp study in type 1 diabetes

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.

Primary endpoints

  • Area under the glucose infusion rate-time curve at steady state (AUC,GIR,SS)

Results so far

None posted. Completed 8 May 2026 with 36 participants. A clamp study is the design most likely to produce a publishable glucose-response curve, so its unpublished result is the single most informative missing datapoint for this route.

The full picture

The smaller and more pointed of Novo Nordisk's two completed Phase 1 studies of NNC0363-1063 in 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".