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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

RECRUITINGPhase 1Sponsored by Novo Nordisk A/S
Actively Recruiting
PhasePhase 1
SponsorNovo Nordisk A/S
Started2025-07-11
Est. completion2026-01-12
Eligibility
Age18 Years – 69 Years
Healthy vol.Accepted

Summary

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).

Eligibility

Age: 18 Years – 69 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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%

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.

Conditions2

DiabetesDiabetes Mellitus, Type 2

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