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

NCT ID: NCT01513525

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2007-05-31

Brief 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.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abdomen

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

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

Thigh

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

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

Upper arm

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

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

Interventions

liraglutide

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Neuss, , Germany

Countries

Germany

References

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. Epub 2010 Jul 29. No abstract available.

Reference Type: RESULT

PMID: 20671294 (View on PubMed)

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2006-004670-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN2211-1745

Identifier Type: -

Identifier Source: org_study_id