Comparison of Two Liraglutide Formulations in Healthy Subjects

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: January 18, 2012
Last updated: January 29, 2015
Last verified: January 2015
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide at pH 8.15 (formulation 4) and liraglutide at pH 7.7 (formulation 3).

Condition Intervention Phase
Drug: liraglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 2 Formulation of Liraglutide at pH 7.7 (Formulation 3) and the Phase 3 Formulation at pH 8.15 (Formulation 4)

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Area under the curve (0-t) [ Designated as safety issue: No ]
  • Cmax, maximum concentration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the curve [ Designated as safety issue: No ]
  • tmax, time to reach Cmax [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
  • Terminal elimination rate constant [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: April 2006
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation 3 Drug: liraglutide
One single dose of 6.25 mg/mL administered subcutaneously
Experimental: Formulation 4 Drug: liraglutide
One single dose of 6.0 mg/mL administered subcutaneously


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  • BMI (Body Mass Index) of 18.0-27.0 kg/m^2, both inclusive

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 trial, as judged by the Investigator
  • Impaired renal function
  • Any clinically significant abnormal ECG, as judged by the Investigator
  • Active hepatitis B and/or active hepatitis C
  • Positive human immunodeficiency virus (HIV) antibodies
  • Known or suspected allergy to trial product(s) or related products
  • Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
  • Use of any prescription or non-prescription medication, except for paracetamol and vitamins, as judged by the Investigator
  Contacts and Locations
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Please refer to this study by its identifier: NCT01515579

Lund, Sweden, 221 85
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S Identifier: NCT01515579     History of Changes
Other Study ID Numbers: NN2211-1693  2005-005948-68 
Study First Received: January 18, 2012
Last Updated: January 29, 2015
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Glucagon-Like Peptide 1
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 11, 2016