Comparison of Liraglutide Injected at Three Different Injection Sites in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Randomised, Open-label, Single Centre, Three Period Cross-over Trial in Healthy Subjects Comparing the Pharmacokinetic Profiles After Single Dose Administration of Liraglutide at Three Different Injection Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513525
• Other study ID #: NN2211-1745
• Secondary ID: 2006-004670-27
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2012
• Last updated: January 25, 2017
• Start date: February 2007
• Est. completion date: May 2007

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 pharmacokinetic profile of liraglutide between administrations in the thigh versus the abdomen and between administrations in the upper arm versus the abdomen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy

• 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

• BMI (Body Mass Index): 18.5-27.5 kg/m^2, both inclusive

Exclusion Criteria:

• Known or suspected allergy to trial product(s) or related products

• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods as required by local law or practice

• The receipt of any investigational drug within 3 months prior to this trial

• History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator

• Impaired renal function

• Active hepatitis B and/or active hepatitis C

• Positive human immunodeficiency virus (HIV) antibodies

• Use of any prescription or non-prescription medication, except for paracetamol and vitamins

• History of alcoholism or drug abuse during the last 12 months.

• Smoking

• Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator

• Excessive consumption of a diet deviating from a normal diet as judged by the Investigator

• Blood donation within the last 3 months

• Plasma donation within the last month

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• liraglutide
Single dose of 0.60 mg administered subcutaneously in three different injection sites on three separate dosing visits

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kapitza C, Zdravkovic M, Zijlstra E, Segel S, Heise T, Flint A. Effect of three different injection sites on the pharmacokinetics of the once-daily human GLP-1 analogue liraglutide. J Clin Pharmacol. 2011 Jun;51(6):951-5. doi: 10.1177/0091270010374474. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Curve (AUC) of liraglutide for each injection site
Secondary	AUC
Secondary	Cmax, maximum concentration
Secondary	tmax, time to maximum concentration
Secondary	t½, terminal half-life
Secondary	Terminal elimination rate constant
Secondary	Relative Bioavailability
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk