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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507389
• Other study ID #: NN2211-1328
• Secondary ID: 2005-003027-38
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2012
• Last updated: December 8, 2014
• Start date: March 2006
• Est. completion date: June 2006

Study information

• Verified date: December 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
Single dose of 0.75 mg injected subcutaneously (under the skin)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Curve (0-infinity)			No
Secondary	Area under the Curve (0-t)			No
Secondary	Cmax, maximum concentration			No
Secondary	tmax, time to maximum concentration			No
Secondary	t½, terminal half-life			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk