A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People With Liver Disease
NCT ID: NCT04597697
Last Updated: 2024-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2020-12-22
2022-03-24
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Subjects with normal hepatic function
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
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.
Subjects with mild hepatic impairment, child-pugh grade A
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
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.
Subjects with moderate hepatic impairment, child-pugh grade B
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
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.
Subjects with severe hepatic impairment, child-pugh grade C
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Pharmaceutical Research Associates CZ, s.r.o.
Prague, , Czechia
Summit Clinical Research s.r.o.
Bratislava, , Slovakia
Countries
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References
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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.
Other Identifiers
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NN1436-4570
Identifier Type: -
Identifier Source: org_study_id
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