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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: liraglutide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild<br> | Drug: liraglutide<br>* Single dose of 0.75 mg injected subcutaneously (under the skin)<br>|
| Experimental: Moderate<br> | Drug: liraglutide<br>* Single dose of 0.75 mg injected subcutaneously (under the skin)<br>|
| Experimental: Severe<br> | Drug: liraglutide<br>* Single dose of 0.75 mg injected subcutaneously (under the skin)<br>|
| Experimental: Normal<br> | Drug: liraglutide<br>* Single dose of 0.75 mg injected subcutaneously (under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Curve (0-infinity) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Curve (0-t) |  |  | 
| Cmax, maximum concentration |  |  | 
| tmax, time to maximum concentration |  |  | 
| t½, terminal half-life |  |  | 
| Adverse events |  |  |