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Completed

NCT Number: NCT04597697

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaceutical Research Associates CZ, s.r.o., Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin icodec

Drug

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.

Primary outcomes

  1. AUC,Ico,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose

    Time frame: Day 1

    From 0 hours until infinity after trial product administration (pmol*h/L)

Secondary outcomes

  1. Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose

    Time frame: Day 1

    From 0 hours until last measurement time after trial product administration (pmol/L)

  2. tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose

    Time frame: Day 1

    From 0 hours until last measurement time after trial product administration (hours)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2020
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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