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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01513525
First received: January 16, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes
Healthy
Drug: liraglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the Curve (AUC) of liraglutide for each injection site [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC [ Designated as safety issue: No ]
  • Cmax, maximum concentration [ Designated as safety issue: No ]
  • tmax, time to maximum concentration [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
  • Terminal elimination rate constant [ Designated as safety issue: No ]
  • Relative Bioavailability [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: February 2007
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513525

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01513525     History of Changes
Other Study ID Numbers: NN2211-1745, 2006-004670-27
Study First Received: January 16, 2012
Last Updated: January 16, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on April 23, 2014