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

NCT ID: NCT01507389

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-06-30

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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mild

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Single dose of 0.75 mg injected subcutaneously (under the skin)

Moderate

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Single dose of 0.75 mg injected subcutaneously (under the skin)

Severe

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Single dose of 0.75 mg injected subcutaneously (under the skin)

Normal

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Single dose of 0.75 mg injected subcutaneously (under the skin)

Interventions

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liraglutide

Single dose of 0.75 mg injected subcutaneously (under the skin)

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Warsaw, , Poland

Site Status

Countries

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Poland

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2005-003027-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN2211-1328

Identifier Type: -

Identifier Source: org_study_id