Status:
COMPLETED
Comparison of the Effect of Liraglutide in Young Versus Elderly Healthy Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare the exposure of liraglutide in young versus elderly healthy subjects.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01507337
Start Date
April 1 2004
End Date
June 1 2004
Last Update
January 24 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Berlin, Germany, 14050