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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507337
• Other study ID #: NN2211-1327
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2012
• Last updated: January 23, 2017
• Start date: April 2004
• Est. completion date: June 2004

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• liraglutide
A single dose of 1 mg administered subcutaneously (under the skin)

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Damholt B, Golor G, Wierich W, Pedersen P, Ekblom M, Zdravkovic M. 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. J Clin Pharmacol. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the liraglutide plasma concentration time curve (AUC 0-t)
Secondary	Area under the liraglutide plasma concentration time curve (AUC 0-infinity)
Secondary	Cmax, maximum liraglutide plasma concentration
Secondary	tmax, time to reach Cmax
Secondary	t½, terminal plasma elimination half-life
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk