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

December 8, 2014 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warszawa, Poland, 01-201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area under the Curve (0-infinity)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

January 6, 2012

First Submitted That Met QC Criteria

January 6, 2012

First Posted (Estimate)

January 10, 2012

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-1328
  • 2005-003027-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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