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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01513525
First received: January 16, 2012
Last updated: January 25, 2017
Last verified: January 2017
  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
Intervention Model: Crossover Assignment
Masking: No masking
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

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

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513525

Locations
Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01513525     History of Changes
Other Study ID Numbers: NN2211-1745
2006-004670-27 ( EudraCT Number )
Study First Received: January 16, 2012
Last Updated: January 25, 2017

Additional relevant MeSH terms:
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 26, 2017