NCT06809621CompletedPhase 1
A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 1 Diabetes When Given by an Insulin Pump
A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of NNC0471-0119 H When Administered as Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
The study is looking at the effect and safety of a new fast-acting insulin (NNC0471 0119) to people with type 1 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters your bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The participants will get each study medicine administered at separate clinic visits. The study will last for about 1-3 months.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 30 Jan 2025
- Start date
- 29 Jan 2025
- Primary completion date
- 16 Jul 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 1 diabetes
- NCT number
- NCT06809621
- EU CT number
- 2024-513472-18-00
- EudraCT number
- 2024-513472-18
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 43
- From 29 Jan 2025 to the primary completion date, 16 Jul 2025
- 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
- Known or suspected hypersensitivity to study intervention(s) or related products.
Other
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
Who the study is looking for
- Male or female aged 18-64 years (both inclusive) at the time of signing the informed consent.
- Diagnosed with Type 1 Diabetes (T1D) greater than or equal to (≥) 1 year before screening.
- Insulin administration using continuous subcutaneous insulin infusion via a pump greater than or equal to (≥) 90 days before screening.
- Current daily insulin treatment between 0.2 and 1.2 Insulin units per kilogram per day \[(I)U/kg/day\] (both inclusive).
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile 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.