Safety of Liraglutide in Subjects With Liver Impairment and in Subjects With Normal Liver Function - Full Text View

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 Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Liraglutide

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Area under the Curve (0-infinity) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Area under the Curve (0-t) [ Designated as safety issue: No ]
Cmax, maximum concentration [ Designated as safety issue: No ]
tmax, time to maximum concentration [ Designated as safety issue: No ]
t½, terminal half-life [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: No ]

Estimated 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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507389

Locations

Poland

Warszawa, Poland, 01-201

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Milan Zdravkovic, MD, PhD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01507389 History of Changes
Other Study ID Numbers:	NN2211-1328, 2005-003027-38
Study First Received:	January 6, 2012
Last Updated:	January 6, 2012
Health Authority:	Poland: Ministry of Health

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 23, 2013