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Comparison of Three Liraglutide Formulations in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514487
First Posted: January 23, 2012
Last Update Posted: March 1, 2017
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.

Condition Intervention Phase
Diabetes Healthy Drug: liraglutide Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Single-centre, Three-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Each of the Two New Liraglutide Formulations at pH 7.9 and 8.15 and the Planned Phase 3 Formulation at pH 7.7

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Area under the curve (0-infinity)
  • tmax, time to reach Cmax
  • t½, terminal half-life
  • Terminal elimination rate constant
  • Adverse events

Enrollment: 24
Actual Study Start Date: January 13, 2005
Study Completion Date: March 30, 2005
Primary Completion Date: March 30, 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pH 7.7 Drug: liraglutide
One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously
Experimental: pH 7.9 Drug: liraglutide
One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously
Experimental: pH 8.15 Drug: liraglutide
One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously

  Eligibility

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
Criteria

Inclusion Criteria:

  • Healthy subjects
  • 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, 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 study, as judged by the investigator
  • Family or personal history of Primary hyperparathyroidism or pheochromocytoma or thyroid malignancy or multiple endocrine neoplasia
  • Impaired renal function
  • Uncontrolled treated/untreated hypertension
  • Any clinically significant abnormal ECG
  • Active hepatitis B and/or active hepatitis C
  • Positive HIV (human immunideficiency virus) 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
  • Prescription or non-prescription medication, except for paracetamol and vitamins
  • 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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01514487


Locations
Australia
Novo Nordisk Investigational Site
Adelaide, Australia, 5000
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: NCT01514487     History of Changes
Other Study ID Numbers: NN2211-1636
First Submitted: January 17, 2012
First Posted: January 23, 2012
Last Update Posted: March 1, 2017
Last Verified: February 2017

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