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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507389
First Posted: January 10, 2012
Last Update Posted: December 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the Curve (0-infinity)

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

Enrollment: 24
Study Start Date: March 2006
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Experimental: Normal Drug: liraglutide
Single dose of 0.75 mg injected subcutaneously (under the skin)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507389


Locations
Poland
Warszawa, Poland, 01-201
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01507389     History of Changes
Other Study ID Numbers: NN2211-1328
2005-003027-38 ( EudraCT Number )
First Submitted: January 6, 2012
First Posted: January 10, 2012
Last Update Posted: December 9, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists