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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01507337

Enrollment

Registered

2012-01-10

Start date

2004-04-30

Completion date

2004-06-30

Last updated

2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

Brief summary

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

DRUGliraglutide

A single dose of 1 mg administered subcutaneously (under the skin)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Area under the liraglutide plasma concentration time curve (AUC 0-t)	—

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026