A Randomised, Double-blind Within Dose Group, Single Centre, Placebo-controlled, Dose Escalation, Multiple s.c. Dose Study to Assess the Safety and Tolerability of Liraglutide 20 ug/kg and 25 ug/kg in Healthy Japanese Male Subjects

Novo Nordisk A/S1 site in 1 country24 target enrollmentJanuary 2006

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsliraglutide placebo

Drugsliraglutide placebo

Overview

Phase: Phase 1
Intervention: liraglutide
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 24
Locations: 1
Primary Endpoint: Antibody against liraglutide
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

April 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy Japanese subjects
•BMI (Body Mass Index) between 18.0-27.0 kg/m\^2 inclusive

Exclusion Criteria

•Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal ECG (electrocardiogram) findings at the screening
•Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
•Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
•History of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
•History of significant allergy or hypersensitivity
•Known or suspected allergy to trial product or related products
•History of drug or alcohol abuse
•The subjects who smoke more than 15 cigarettes, or the equivalent, per day and is unwilling to refrain from smoking whenever required for the trial procedure