NCT04597697

A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People With Liver Disease

A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec in Subjects With Various Degrees of Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Participants will receive one insulin icodec dose, which will be administered in the morning of the day of dosing. The study will last for about 8 weeks. Participants will have 8 visits with the study doctor in the clinical research unit. Insulin icodec will be injected into a skin fold with a small needle (subcutaneous application) using a pen injector prefilled with a volume of 3 mL (about a spoonful). Participants must not participate if they meet certain conditions called exclusion criteria, such as an age of below 18 years or above 70 years, if participants are over- or underweight, using certain medicines, or have serious health conditions (other than impaired liver function ). Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Insulin icodec	Insulin icodec will be investigated in participants with impaired liver function and subjects with normal liver function. Administered as a single dose subcutaneously (under the skin) The study will last for about 8 weeks.

Timeline

• Start date: 2020-12-22
• Primary completion: 2022-03-24
• Completion: 2022-03-24
• First posted: 2020-10-22
• Last updated: 2024-07-12

Locations

2 sites across 2 countries: Czechia, Slovakia