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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
  Purpose
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of two formulations of liraglutide.

Condition Intervention Phase
Diabetes
Healthy
Drug: liraglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the Curve (AUC) (0-t)
  • Cmax, maximum concentration

Secondary Outcome Measures:
  • AUC (0-infinity)
  • tmax, time to maximum concentration
  • t½, terminal half-life
  • Terminal elimination rate constant
  • Adverse events

Enrollment: 22
Actual Study Start Date: May 28, 2004
Study Completion Date: June 30, 2004
Primary Completion Date: June 30, 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 2 formulation Drug: liraglutide
Single dose administered as subcutaneous injection
Experimental: Phase 3 formulation Drug: liraglutide
Single dose administered as subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01508897

Locations
Germany
Novo Nordisk Investigational Site
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01508897     History of Changes
Other Study ID Numbers: NN2211-1331
Study First Received: January 9, 2012
Last Updated: February 28, 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 March 28, 2017