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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NN2211-1327

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare the exposure of liraglutide in young versus elderly healthy subjects.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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