Clinical trial NCT04597697: A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People With Liver Disease
Official title: A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec in Subjects With Various Degrees of Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: AUC,Ico,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose
timeFrame: Day 1
Secondary outcomes:
measure: Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose
timeFrame: Day 1
measure: tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose
timeFrame: Day 1
Other outcomes:
Locations:
city: Praha 7
country: Czechia
facility: Pharmaceutical Research Associates CZ, s.r.o.
city: Bratislava
country: Slovakia
facility: Summit Clinical Research s.r.o.
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References:
citation: 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.