NCT07305805

A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes

A Multiple Dose Study Investigating Pharmacodynamics and Pharmacokinetics of Subcutaneous NNC0363-1063 in Participants With Type 1 Diabetes

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to find out how the novel insulin NNC0363-1063 and a non-glucose carbohydrate used in food and beverage might interact in participants with type 1 diabetes and if co-administration of these substances is safe and tolerable. All participants will get a fixed dose of NNC0363-1063 and an oral administration of different amounts of the non-glucose carbohydrate in a random order during 4 interaction tests. The participants will be in this clinical study for about 5 to 12 weeks.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	NNC0363-1063	NNC0363-1063 will be administered subcutaneously.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-05-17
• Completion: 2026-05-21
• First posted: 2025-12-26
• Last updated: 2026-01-02

Locations

1 site across 1 country: Germany