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Completed
NCT06809621
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
Conditions: Diabetes Mellitus, Type 1
Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 43
Sponsor: Novo Nordisk A/S
Location: Profil Institut für Stoffwechselforschung GmbH Neuss
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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).
Exclusion Criteria:
* Known or suspected hypersensitivity to study intervention(s) or related products.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
Source: ClinicalTrials.gov (NCT06809621). StuddyBuddy aggregates publicly available trial information.