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

Last updated: August 29, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

1

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 1

Diabetes Prevention

Treatment

NNC0471-0119 H

Insulin aspart

Clinical Study ID

NCT06809621
NN1471-7712
2024-513472-18
U1111-1306-8005
  • Ages 18-64
  • All Genders

Study 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

Inclusion Criteria:

  • Male or female aged 18-64 years (both inclusive) at the time of signing the informedconsent.

  • Diagnosed with Type 1 Diabetes (T1D) greater than or equal to (≥) 1 year beforescreening.

  • Insulin administration using continuous subcutaneous insulin infusion via a pumpgreater than or equal to (≥) 90 days before screening.

  • Current daily insulin treatment between 0.2 and 1.2 Insulin units per kilogram perday [(I)U/kg/day] (both inclusive).

Exclusion

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 ofchild-bearing potential and not using adequate contraceptive methods.

Study Design

Total Participants: 43
Treatment Group(s): 2
Primary Treatment: NNC0471-0119 H
Phase: 1
Study Start date:
January 29, 2025
Estimated Completion Date:
July 28, 2025

Connect with a study center

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460
    Germany

    Site Not Available

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss 2864118, 41460
    Germany

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.