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: January 30, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetes Mellitus, Type 1

Diabetes And Hypertension

Diabetes Prevention

Treatment

Insulin aspart

NNC0471-0119 H

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: Insulin aspart
Phase: 1
Study Start date:
January 28, 2025
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460
    Germany

    Active - Recruiting

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