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

Phase 1

Completed

• Conditions: Healthy; Diabetes
• Interventions: Drug: insulin degludec

• Registration Number: NCT00976326
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C: Subjects with moderate liver impairment	insulin degludec	-
A: Healthy volunteers	insulin degludec	-
B: Subjects with mild liver impairment	insulin degludec	-
D: Subjects with severe liver impairment	insulin degludec	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇰 Bratislava, Slovakia