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

NCT04597697 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-07-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 1452) · Novo Nordisk A/S

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-22
Primary Completion
2022-03-24
Completion
2022-03-24

Countries

  • Czechia
  • Slovakia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597697 on ClinicalTrials.gov