Safety of Liraglutide in Subjects With Liver Impairment and in Subjects With Normal Liver Function

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01507389

NN2211-1328

2005-003027-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Mild

Experimental group

Treatment:

Drug: liraglutide

Moderate

Experimental group

Treatment:

Drug: liraglutide

Severe

Experimental group

Treatment:

Drug: liraglutide

Normal

Experimental group

Treatment:

Drug: liraglutide