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

January 25, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abdomen
Drug: liraglutide
Single dose of 0.60 mg administered subcutaneously in three different injection sites on three separate dosing visits
Experimental: Thigh
Drug: liraglutide
Single dose of 0.60 mg administered subcutaneously in three different injection sites on three separate dosing visits
Experimental: Upper arm
Drug: liraglutide
Single dose of 0.60 mg administered subcutaneously in three different injection sites on three separate dosing visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area under the Curve (AUC) of liraglutide for each injection site

Secondary Outcome Measures

Outcome Measure
Adverse events
Cmax, maximum concentration
t½, terminal half-life
Terminal elimination rate constant
AUC
tmax, time to maximum concentration
Relative Bioavailability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 16, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-1745
  • 2006-004670-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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