16 September 2026 editorial review · Trial
NNC0363-1063: first-in-human glucose-sensitive insulin in type 1 diabetes: review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the trial evidence page →Baseline trial evidence review: M–S
Outcome: Removed false first-human class milestone using earlier primary MK2640 humanT1D trial (PMID30125349).
Registry: NCT06685185. Endpoint reviewed: Part 1 SAD: Number of adverse events (From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)); Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose (From IMP administration at day 1 up to 7 days); Part 3 Meal test: AUC,PG,meal: Area under the plasma glucose concentration-time curve at steady state (At day 2 of visit 2 and visit 3 after initiation of meal test). Eligibility reviewed: Age 18 Years to 64 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Earlier MK-2640 human primary study.