Status:
COMPLETED
Safety of Liraglutide in Subjects With Liver Impairment and in Subjects With Normal Liver Function
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 hepat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01507389
Start Date
March 1 2006
End Date
June 1 2006
Last Update
December 9 2014
Active Locations (1)
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1
Warsaw, Poland, 01-201