A Trial Investigating the Pharmacokinetic (Mode of Action in the Body) and Safety Profiles of NN1250 (Insulin Degludec) in Subjects With Various Degrees of Impaired Liver Function and in Subjects With Normal Liver Function

Study Overview
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Brief Summary
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This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects with impaired liver function compared to the dose for subjects with normal liver function.

Official Title
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A Trial Investigating the Pharmacokinetic and Safety Profiles of NN1250 in Subjects With Mild, Moderate and Severe Degrees of Hepatic Impairment and in Subjects With Normal Hepatic Function

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: insulin degludec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with normal hepatic function, liver parameters within normal range. Not assessed with the Child-Pugh criteria. Or: Subject with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by Investigator Body mass index maximum 40.0 kg/m^2 Exclusion Criteria: Subject with any disease or condition which the Investigator feels would interfere with the trial outcome or execution except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Not able or willing to refrain from smoking during the inpatient period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Healthy volunteers<br> | Drug: insulin degludec<br>* The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)<br>|
| Experimental: B: Subjects with mild liver impairment<br> | Drug: insulin degludec<br>* The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)<br>|
| Experimental: C: Subjects with moderate liver impairment<br> | Drug: insulin degludec<br>* The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)<br>|
| Experimental: D: Subjects with severe liver impairment<br> | Drug: insulin degludec<br>* The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the NN1250 concentration-time curve after single-dose |  | from 0 to 120 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed NN1250 concentration after single-dose |  | from 0 to 120 hours | 
| Renal clearance of NN1250 |  | from 0 to 24 hours | 
| Number of adverse events |  | from Visit 2, Day -1 until Follow-up Visit |