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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01507389
First received: January 6, 2012
Last updated: March 26, 2014
Last verified: March 2014
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Poland
Warszawa, Poland, 01-201
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01507389     History of Changes
Other Study ID Numbers: NN2211-1328
Study First Received: January 6, 2012
Last Updated: March 26, 2014
Health Authority: Poland: Ministry of Health

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

ClinicalTrials.gov processed this record on October 20, 2014