Comparison of Two Liraglutide Formulations in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01515579
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : January 30, 2015
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Healthy Drug: liraglutide Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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)
Study Start Date : April 2006
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Area under the curve (0-t)
  2. Cmax, maximum concentration

Secondary Outcome Measures :
  1. Area under the curve
  2. tmax, time to reach Cmax
  3. t½, terminal half-life
  4. Terminal elimination rate constant
  5. Adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01515579

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

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01515579     History of Changes
Other Study ID Numbers: NN2211-1693
2005-005948-68 ( EudraCT Number )
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists