Safety of Liraglutide in Subjects With Liver Impairment and in Subjects With Normal Liver Function
- Registration Number
- NCT01507389
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate liraglutide - Mild liraglutide - Severe liraglutide - Normal liraglutide -
- Primary Outcome Measures
Name Time Method Area under the Curve (0-infinity)
- Secondary Outcome Measures
Name Time Method Area under the Curve (0-t) Cmax, maximum concentration tmax, time to maximum concentration t½, terminal half-life Adverse events