RecruitingPhase 1NCT07068295

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


Sponsor

Novo Nordisk A/S

Enrollment

65 participants

Start Date

Jul 11, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study is testing how a new experimental long-acting insulin (NNC0471-0119 H) behaves when delivered through an insulin pump in people with type 2 diabetes — examining how it is absorbed, circulates in the bloodstream, and clears from the body compared to standard insulins. This helps determine the correct dosing and safety profile before broader testing. **You may be eligible if...** - You are 18 to 69 years old - You have been diagnosed with type 2 diabetes for at least 6 months - You have been using injectable insulin for at least 6 months at a consistent dose - Your long-term blood sugar marker (HbA1c) is 9.5% or below - Your body mass index (BMI) is between 18.5 and 34.9 - You are NOT currently using a once-weekly insulin formulation **You may NOT be eligible if...** - You have a known allergy to the study drug or similar insulins - You are pregnant, breastfeeding, or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNNC0471-0119 H

NNC0471-0119 H will be administered subcutaneously.

DRUGInsulin Aspart

Insulin aspart will be administered subcutaneously.


Locations(1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

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NCT07068295


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