Safety of Liraglutide in Subjects With Liver Impairment and in Subjects With Normal Liver Function
A Single-centre, Open-label Trial Investigating the Pharmacokinetics and the Safety Profile After a Single Dose of Liraglutide in Subjects With Hepatic Impairment and in Subjects With Normal Hepatic Function
2 other identifiers
interventional
24
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate liraglutide in subjects with mild, moderate and severe degrees of hepatic impairment compared with subjects with normal hepatic function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes
Started Mar 2006
Shorter than P25 for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 6, 2012
CompletedFirst Posted
Study publicly available on registry
January 10, 2012
CompletedDecember 9, 2014
December 1, 2014
3 months
January 6, 2012
December 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the Curve (0-infinity)
Secondary Outcomes (5)
Area under the Curve (0-t)
Cmax, maximum concentration
tmax, time to maximum concentration
t½, terminal half-life
Adverse events
Study Arms (4)
Mild
EXPERIMENTALModerate
EXPERIMENTALSevere
EXPERIMENTALNormal
EXPERIMENTALInterventions
Single dose of 0.75 mg injected subcutaneously (under the skin)
Eligibility Criteria
You may qualify if:
- Subjects with normal hepatic function and liver parameters within normal range
- Subjects with stable hepatic impairment classified as Child-Pugh grade A, B or C
- Body Mass Index between 18.5-40.0 kg/m\^2 (both inclusive)
You may not qualify if:
- Known or suspected allergy to trial product or related products
- Liver transplanted subjects
- Cardiac problems
- Uncontrolled treated/untreated hypertension
- Signs of acute liver insufficiency
- Positive HIV (human immunodeficiency virus) 1+2 antibodies
- Cancer or any clinically significant disease or disorder except for conditions associated with the hepatic impairment
- Impaired renal function
- Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
- Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Warsaw, 01-201, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2012
First Posted
January 10, 2012
Study Start
March 1, 2006
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
December 9, 2014
Record last verified: 2014-12