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Recruiting Phase 1 NCT07068295

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

Trial Parameters

Condition Diabetes Mellitus, Type 2
Sponsor Novo Nordisk A/S
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 65
Sex ALL
Min Age 18 Years
Max Age 69 Years
Start Date 2025-07-11
Completion 2026-01-12
Interventions
NNC0471-0119 HInsulin Aspart

Brief 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 Criteria

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

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