NCT07068295CompletedPhase 1
A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 2 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 2 Diabetes
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
This study looks at the effect and safety of a new fast-acting insulin (NNC0471-0119) in people with type 2 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters 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 study will last for about 13-67 days (or a half to 2 months).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 65 (actual)
- First submitted
- 7 Jul 2025
- Start date
- 11 Jul 2025
- Primary completion date
- 22 Feb 2026
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT07068295
- EU CT number
- 2024-520230-29-00
- EudraCT number
- 2024-520230-29
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 65
- From 11 Jul 2025 to the primary completion date, 22 Feb 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
- 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 (sex at birth).
- Age 18-69 years (both inclusive) at the time of signing the informed consent.
- Diagnosed with Type 2 Diabetes (T2D) greater than or equal to (≥) 180 days before screening.
- Treated with any injectable insulin, except once-weekly insulin, ≥ 180 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) with or without the following anti-diabetic drugs with stable doses ≥ 90 days prior to the day of screening:
- Any metformin formulation
- Dipeptidyl peptidase-4 inhibitor (DPP4i)
- Sodium-glucose Cotransporter-2 inhibitor (SGLT2i)
- Body mass index (BMI) between 18.5 and 34.9 kg/m2 (both inclusive) at screening.
- HbA1c lesser than or equal to (≤) 9.5%
Age in the registry: 18 years to 69 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.