A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
117actual
Sites
1
Country
Germany
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-11-12 | actual | When the study began enrolling |
| Primary completion | 2026-03-08 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-03-18 | actual | The whole study's end, after follow-up |
| First posted | 2024-11-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Diabetes Mellitus, Type 1
Interventions
- Drug: NNC0363-1063
- Drug: Placebo
- Drug: Insulin degludec — also filed as Tresiba
- Drug: Insulin detemir — also filed as Levemir
Primary outcomes
what the primary-completion date above is the date OFPart 1 SAD: Number of adverse events
measured 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
measured 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
measured At day 2 of visit 2 and visit 3 after initiation of meal test
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