NCT07305805CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 12 Dec 2025
- Start date
- 16 Dec 2025
- Primary completion date
- 21 Apr 2026
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 1 diabetes
- NCT number
- NCT07305805
- EU CT number
- 2025-521593-33-00
- EudraCT number
- 2025-521593-33
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 36
- From 16 Dec 2025 to the primary completion date, 21 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Age
- Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
Who the study is looking for
- Male or female participant (sex at birth) of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e., documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 month without an alternative medical cause) prior to the day of screening.
- Age 18-64 years (both inclusive) at the time of signing informed consent.
- Body mass index between 18.5-29.9 Kilogram Per Square Meter (kg/m\^2) (both inclusive) at the day of screening.
- Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year prior to the day of screening.
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion ≥ 90 days prior to the day of screening.
- Glycated haemoglobin (HbA1c) less than or equal to (≤ ) 9.0 percentage (%) at the day of screening.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PROFIL Institut fuer Stoffwechselforschung GmbH Coordinator of this site? Confirm its status | Neuss | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.