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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
View on ClinicalTrials.gov →
NCT07068295
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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Actively Recruiting
PhasePhase 1
SponsorNovo Nordisk A/S
Started2025-07-11
Est. completion2026-01-12
Eligibility
Age18 Years – 69 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07068295