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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Poland

Study Type

Interventional

Intervention

liraglutide

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Mild

Moderate

Severe

Normal

Arm Description

Outcomes

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

Full Information

NCT ID

NCT01507389

First Posted

January 6, 2012

Last Updated

December 8, 2014

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01507389

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mild

Arm Type

Experimental

Arm Title

Moderate

Arm Type

Experimental

Arm Title

Severe

Arm Type

Experimental

Arm Title

Normal

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

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

Primary Outcome Measure Information:

Title

Area under the Curve (0-infinity)

Secondary Outcome Measure Information:

Title

Area under the Curve (0-t)

Title

Cmax, maximum concentration

Title

tmax, time to maximum concentration

Title

t½, terminal half-life

Title

Adverse events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

City

Warszawa

ZIP/Postal Code

01-201

Country

Poland

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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