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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00976326

Enrollment

Registered

2009-09-14

Start date

2009-08-31

Completion date

2010-03-31

Last updated

2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

Brief summary

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.

Interventions

DRUGinsulin degludec

The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Area under the NN1250 concentration-time curve after single-dose	from 0 to 120 hours

Secondary

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

Countries

Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026