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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01507337
First received: January 6, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the liraglutide plasma concentration time curve (AUC 0-infinity) [ Designated as safety issue: No ]
  • Cmax, maximum liraglutide plasma concentration [ Designated as safety issue: No ]
  • tmax, time to reach Cmax [ Designated as safety issue: No ]
  • t½, terminal plasma elimination half-life [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507337

Locations
Germany
Berlin, Germany, 14050
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01507337     History of Changes
Other Study ID Numbers: NN2211-1327
Study First Received: January 6, 2012
Last Updated: January 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 18, 2014