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Comparison of the Effect of Liraglutide in Young Versus Elderly Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507337
First Posted: January 10, 2012
Last Update Posted: January 24, 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 Europe. The aim of this trial is to compare the exposure of liraglutide in young versus elderly healthy subjects.

Condition Intervention Phase
Diabetes Healthy Drug: liraglutide Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single Dose Trial With Two Groups Comparing the Pharmacokinetics of Liraglutide in Young Versus Elderly Healthy Subjects of Both Sexes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the liraglutide plasma concentration time curve (AUC 0-t)

Secondary Outcome Measures:
  • Area under the liraglutide plasma concentration time curve (AUC 0-infinity)
  • Cmax, maximum liraglutide plasma concentration
  • tmax, time to reach Cmax
  • t½, terminal plasma elimination half-life
  • Adverse events

Enrollment: 32
Study Start Date: April 2004
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elderly Drug: liraglutide
A single dose of 1 mg administered subcutaneously (under the skin)
Experimental: Young Drug: liraglutide
A single dose of 1 mg administered subcutaneously (under the skin)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Age, young subjects: age 18-45 years (both incl.)
  • Age, elderly subjects: age at least 65 years
  • Body Mass Index (BMI) 18-30 kg/m^2 (both incl.)
  • Blood pressure, young: Diastolic 50-90 mmHg, systolic 90-140 mmHg
  • Blood pressure, elderly: Diastolic 50-95 mmHg, systolic 92-160 mmHg

Exclusion Criteria:

  • History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease, or other major disorders that could interfere with the objectives of the trial, as judged by the investigator
  • Impaired renal function
  • Any clinically significant abnormal ECG (electrocardiogram)
  • Active hepatitis B and/or active hepatitis C
  • Positive HIV (human immunodeficiency virus) antibodies
  • Febrile illness within 5 days prior to first administration of liraglutide
  • 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): NCT01507337


Locations
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01507337     History of Changes
Other Study ID Numbers: NN2211-1327
First Submitted: January 6, 2012
First Posted: January 10, 2012
Last Update Posted: January 24, 2017
Last Verified: January 2017

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