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OpenTrials
Completed

NCT Number: NCT01507389

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

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Warsaw, 01-201, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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

Primary outcomes

  1. Area under the Curve (0-infinity)

Secondary outcomes

  1. Area under the Curve (0-t)

  2. Cmax, maximum concentration

  3. tmax, time to maximum concentration

  4. t½, terminal half-life

  5. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jan 10, 2012
Registry last updated
Dec 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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