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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597697
• Other study ID #: NN1436-4570
• Status: Completed
• Phase: Phase 1
• Start date: December 22, 2020
• Est. completion date: March 24, 2022

Study information

• Verified date: November 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 24, 2022
• Est. primary completion date: March 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female

• Aged 18-70 years (both inclusive) at the time of signing informed consent

• Body mass index between 18.5 and 39.9 kg/m^2 (both inclusive) Specific inclusion criterion only for subjects with hepatic impairment

• Subjects with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.

Exclusion Criteria:

• Known or suspected hypersensitivity to trial product or related products

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

• Diagnosis of diabetes mellitus

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Czechia	Novo Nordisk Investigational Site	Praha 7
Slovakia	Novo Nordisk Investigational Site	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Czechia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC,Ico,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose	From 0 hours until infinity after trial product administration (pmol*h/L)	Day 1
Secondary	Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose	From 0 hours until last measurement time after trial product administration (pmol/L)	Day 1
Secondary	tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose	From 0 hours until last measurement time after trial product administration (hours)	Day 1