Comparison of Liraglutide Injected at Three Different Injection Sites in Healthy Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01513525

NN2211-1745

2006-004670-27 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. the aim of this trial is to compare the pharmacokinetic profile of liraglutide between administrations in the thigh versus the abdomen and between administrations in the upper arm versus the abdomen.

Enrollment: 21 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy
• 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
• BMI (Body Mass Index): 18.5-27.5 kg/m^2, both inclusive

Exclusion criteria

• Known or suspected allergy to trial product(s) or related products
• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods as required by local law or practice
• The receipt of any investigational drug within 3 months prior to this trial
• History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator
• Impaired renal function
• Active hepatitis B and/or active hepatitis C
• Positive human immunodeficiency virus (HIV) antibodies
• Use of any prescription or non-prescription medication, except for paracetamol and vitamins
• History of alcoholism or drug abuse during the last 12 months.
• Smoking
• Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator
• Excessive consumption of a diet deviating from a normal diet as judged by the Investigator
• Blood donation within the last 3 months
• Plasma donation within the last month

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Abdomen

Experimental group

Treatment:

Drug: liraglutide

Thigh

Experimental group

Treatment:

Drug: liraglutide

Upper arm

Experimental group

Treatment:

Drug: liraglutide