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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin, Long-Acting

Criteria

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