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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin icodec

Study type: Interventional

Funder types: Industry

Identifiers

NCT04597697

NN1436-4570

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 4 patient groups

Subjects with normal hepatic function

Experimental group

Description:

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

Treatment:

Drug: Insulin icodec

Subjects with mild hepatic impairment, child-pugh grade A

Experimental group

Description:

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

Treatment:

Drug: Insulin icodec

Subjects with moderate hepatic impairment, child-pugh grade B

Experimental group

Description:

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

Treatment:

Drug: Insulin icodec

Subjects with severe hepatic impairment, child-pugh grade C

Experimental group

Description:

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

Treatment:

Drug: Insulin icodec