NCT01513525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

January 16, 2012

Last Update Submit

January 25, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

  • AUC

  • Cmax, maximum concentration

  • tmax, time to maximum concentration

  • t½, terminal half-life

  • Terminal elimination rate constant

  • +2 more secondary outcomes

Study Arms (3)

Abdomen

EXPERIMENTAL
Drug: liraglutide

Thigh

EXPERIMENTAL
Drug: liraglutide

Upper arm

EXPERIMENTAL
Drug: liraglutide

Interventions

liraglutideDRUG

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

AbdomenThighUpper arm

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related 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. Epub 2010 Jul 29. No abstract available.

    PMID: 20671294RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2012

First Posted

January 20, 2012

Study Start

February 1, 2007

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

DE(1)