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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: January 6, 2012
Last updated: January 23, 2017
Last verified: January 2017
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
Drug: liraglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01507337

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

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01507337     History of Changes
Other Study ID Numbers: NN2211-1327
Study First Received: January 6, 2012
Last Updated: January 23, 2017

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 22, 2017