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
Novo Nordisk A/S
65 participants
Jul 11, 2025
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
Inclusion Criteria10
- 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 Criteria2
- 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.
Interventions
NNC0471-0119 H will be administered subcutaneously.
Insulin aspart will be administered subcutaneously.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07068295