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

NCT ID: NCT00976326

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-03-31

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.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A: Healthy volunteers

Group Type: EXPERIMENTAL

insulin degludec

Intervention Type: DRUG

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

B: Subjects with mild liver impairment

Group Type: EXPERIMENTAL

insulin degludec

Intervention Type: DRUG

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

C: Subjects with moderate liver impairment

Group Type: EXPERIMENTAL

insulin degludec

Intervention Type: DRUG

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

D: Subjects with severe liver impairment

Group Type: EXPERIMENTAL

insulin degludec

Intervention Type: DRUG

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

Interventions

insulin degludec

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Bratislava, , Slovakia

Countries

Slovakia

References

Kupcova V, Arold G, Roepstorff C, Hojbjerre M, Klim S, Haahr H. Insulin degludec: pharmacokinetic properties in subjects with hepatic impairment. Clin Drug Investig. 2014 Feb;34(2):127-33. doi: 10.1007/s40261-013-0154-1.

Reference Type: RESULT

PMID: 24277680 (View on PubMed)

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2009-009465-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN1250-1989

Identifier Type: -

Identifier Source: org_study_id