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Comparison of Two Liraglutide Formulations in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01508897
First received: January 9, 2012
Last updated: February 28, 2017
Last verified: February 2017
January 9, 2012
February 28, 2017
May 28, 2004
June 30, 2004   (Final data collection date for primary outcome measure)
  • Area under the Curve (AUC) (0-t)
  • Cmax, maximum concentration
Same as current
Complete list of historical versions of study NCT01508897 on ClinicalTrials.gov Archive Site
  • AUC (0-infinity)
  • tmax, time to maximum concentration
  • t½, terminal half-life
  • Terminal elimination rate constant
  • Adverse events
Same as current
Not Provided
Not Provided
 
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
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of two formulations of liraglutide.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant
Primary Purpose: Treatment
  • Diabetes
  • Healthy
Drug: liraglutide
Single dose administered as subcutaneous injection
  • Experimental: Phase 2 formulation
    Intervention: Drug: liraglutide
  • Experimental: Phase 3 formulation
    Intervention: Drug: liraglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
June 30, 2004
June 30, 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Not Provided
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01508897
NN2211-1331
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP