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Trial · Interventional

CompletedPhase 1Registry data

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

Overview

Status
Completed
Phase
Phase 1
Enrollment
32 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

Germany

Start
Apr 2004
Primary completion
Jun 2004
Completion
Jun 2004
First posted
10 Jan 2012 (estimated)
Last update posted
24 Jan 2017 (estimated)
Conditions
Diabetes · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042005
  1. Ph 1

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

    NCT01507337

    Apr 2004 to Jun 2004

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • liraglutideDrug

Arms2

  • Experimental

    Elderly

  • Experimental

    Young

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Area under the liraglutide plasma concentration time curve (AUC 0-t)

Secondary outcomes(5)
  1. Area under the liraglutide plasma concentration time curve (AUC 0-infinity)

  2. Cmax, maximum liraglutide plasma concentration

  3. tmax, time to reach Cmax

  4. t½, terminal plasma elimination half-life

  5. Adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2006

6 results

An open-label, parallel group study investigating the effects of age and gender on the pharmacokinetics of the once-daily glucagon-like peptide-1 analogue liraglutide.

Damholt et al. 2006Journal of clinical pharmacologycited by 61

PMID 16707410DOI 10.1177/0091270006288215PUB-16707410

Full text at the publisher6 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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