Comparison of Two Liraglutide Formulations in Healthy Volunteers
A Randomized, Single-blind, Single-centre, Two-period, Cross-over Trial Investigating the Bioequivalence Between Completed Phase 2 and Planned Phase 3 Formulations of Liraglutide in Healthy Subjects
1 other identifier
interventional
22
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of two formulations of liraglutide.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes
Started May 2004
Shorter than P25 for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 28, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2004
CompletedFirst Submitted
Initial submission to the registry
January 9, 2012
CompletedFirst Posted
Study publicly available on registry
January 12, 2012
CompletedJanuary 2, 2024
February 1, 2017
1 month
January 9, 2012
December 29, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the Curve (AUC) (0-t)
Cmax, maximum concentration
Secondary Outcomes (5)
AUC (0-infinity)
tmax, time to maximum concentration
t½, terminal half-life
Terminal elimination rate constant
Adverse events
Study Arms (2)
Phase 2 formulation
EXPERIMENTALPhase 3 formulation
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
- Body Mass Index (BMI) of 18-27 kg/m\^2 incl.
You may not qualify if:
- 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 study, as judged by the investigator
- Impaired renal function
- Uncontrolled treated/untreated hypertension
- Any clinically significant abnormal ECG
- Active hepatitis B and/or active hepatitis C
- Positive HIV (human immunodeficiency virus) antibodies
- History of alcoholism or drug abuse during the last 12 months
- Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
- Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
- Excessive consumption of a diet deviating from a normal diet as judged by the Investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Neu-Ulm, 89231, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2012
First Posted
January 12, 2012
Study Start
May 28, 2004
Primary Completion
June 30, 2004
Study Completion
June 30, 2004
Last Updated
January 2, 2024
Record last verified: 2017-02