Comparison of the Effect of Liraglutide in Young Versus Elderly Healthy Volunteers

January 23, 2017 updated by: Novo Nordisk A/S

An Open Label, Single Dose Trial With Two Groups Comparing the Pharmacokinetics of Liraglutide in Young Versus Elderly Healthy Subjects of Both Sexes

This trial is conducted in Europe. The aim of this trial is to compare the exposure of liraglutide in young versus elderly healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14050
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, and blood and urinary laboratory assessments
  • Age, young subjects: age 18-45 years (both incl.)
  • Age, elderly subjects: age at least 65 years
  • Body Mass Index (BMI) 18-30 kg/m^2 (both incl.)
  • Blood pressure, young: Diastolic 50-90 mmHg, systolic 90-140 mmHg
  • Blood pressure, elderly: Diastolic 50-95 mmHg, systolic 92-160 mmHg

Exclusion Criteria:

  • History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease, or other major disorders that could interfere with the objectives of the trial, as judged by the investigator
  • Impaired renal function
  • Any clinically significant abnormal ECG (electrocardiogram)
  • Active hepatitis B and/or active hepatitis C
  • Positive HIV (human immunodeficiency virus) antibodies
  • Febrile illness within 5 days prior to first administration of liraglutide
  • History of alcoholism or drug abuse during the last 12 months
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Elderly
Drug: liraglutide
A single dose of 1 mg administered subcutaneously (under the skin)
EXPERIMENTAL: Young
Drug: liraglutide
A single dose of 1 mg administered subcutaneously (under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area under the liraglutide plasma concentration time curve (AUC 0-t)

Secondary Outcome Measures

Outcome Measure
Adverse events
tmax, time to reach Cmax
Area under the liraglutide plasma concentration time curve (AUC 0-infinity)
Cmax, maximum liraglutide plasma concentration
t½, terminal plasma elimination half-life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (ACTUAL)

June 1, 2004

Study Completion (ACTUAL)

June 1, 2004

Study Registration Dates

First Submitted

January 6, 2012

First Submitted That Met QC Criteria

January 6, 2012

First Posted (ESTIMATE)

January 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-1327

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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