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

NCT04597697 | Completed Phase 1

• 1 other identifier: NN1436-4570
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Day 1

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

  Day 1

Study Arms (4)

Subjects with normal hepatic function

EXPERIMENTAL

The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.

Drug: Insulin icodec

Subjects with mild hepatic impairment, child-pugh grade A

EXPERIMENTAL

The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.

Drug: Insulin icodec

Subjects with moderate hepatic impairment, child-pugh grade B

EXPERIMENTAL

The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.

Drug: Insulin icodec

Subjects with severe hepatic impairment, child-pugh grade C

EXPERIMENTAL

The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.

Drug: Insulin icodec

Interventions

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.

Subjects with mild hepatic impairment, child-pugh grade A; Subjects with moderate hepatic impairment, child-pugh grade B; Subjects with normal hepatic function; Subjects with severe hepatic impairment, child-pugh grade C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Pharmaceutical Research Associates CZ, s.r.o.

Prague, 17000, Czechia

Location

Summit Clinical Research s.r.o.

Bratislava, 83101, Slovakia

Location

Related Publications (1)

• Haahr H, Cieslarova B, Hingst JR, Jiang S, Kristensen NR, Kupcova V, Norgreen L, Wagner FH, Ignatenko S. The Effect of Various Degrees of Renal or Hepatic Impairment on the Pharmacokinetic Properties of Once-Weekly Insulin Icodec. Clin Pharmacokinet. 2024 Jun;63(6):819-830. doi: 10.1007/s40262-024-01375-2. Epub 2024 May 9.

  PMID: 38722461 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin icodec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: December 22, 2020
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2022
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

SL (1); CZ (1)