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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT04597697

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

12.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Insulin icodec	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 22, 2020

Actual Primary Completion Date :

Mar 24, 2022

Actual Study Completion Date :

Mar 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects with normal hepatic function The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.	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.
Experimental: Subjects with mild hepatic impairment, child-pugh grade A The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.	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.
Experimental: Subjects with moderate hepatic impairment, child-pugh grade B The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.	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.
Experimental: Subjects with severe hepatic impairment, child-pugh grade C The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.	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.

Outcome Measures

Primary Outcome Measures

AUC,Ico,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose [Day 1]
From 0 hours until infinity after trial product administration (pmol*h/L)

Secondary Outcome Measures

Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose [Day 1]
From 0 hours until last measurement time after trial product administration (pmol/L)
tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose [Day 1]
From 0 hours until last measurement time after trial product administration (hours)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Praha 7		Czechia	17000
2	Novo Nordisk Investigational Site	Bratislava		Slovakia	83101

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT04597697

Other Study ID Numbers:

NN1436-4570

First Posted:

Oct 22, 2020

Last Update Posted:

Jun 7, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Insulin

Study Results

No Results Posted as of Jun 7, 2022