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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: insulin degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT00976326

2009-009465-34 (EudraCT Number)

NN1250-1989

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

A: Healthy volunteers

Experimental group

Treatment:

Drug: insulin degludec

B: Subjects with mild liver impairment

Experimental group

Treatment:

Drug: insulin degludec

C: Subjects with moderate liver impairment

Experimental group

Treatment:

Drug: insulin degludec

D: Subjects with severe liver impairment

Experimental group

Treatment:

Drug: insulin degludec