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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976326
• Other study ID #: NN1250-1989
• Secondary ID: 2009-009465-34
• Status: Completed
• Phase: Phase 1
• First received: September 11, 2009
• Last updated: January 19, 2017
• Start date: August 2009
• Est. completion date: March 2010

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Slovakia	Novo Nordisk Investigational Site	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Slovakia, 

References & Publications (1)

Kupcová V, Arold G, Roepstorff C, Højbjerre 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the NN1250 concentration-time curve after single-dose		from 0 to 120 hours
Secondary	Maximum observed NN1250 concentration after single-dose		from 0 to 120 hours
Secondary	Renal clearance of NN1250		from 0 to 24 hours
Secondary	Number of adverse events		from Visit 2, Day -1 until Follow-up Visit

External Links

•   Clinical Trials at Novo Nordisk