Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: liraglutide; Drug: placebo

• Registration Number: NCT01515592
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-24
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
20 mcg/kg	placebo	-
15 mcg/kg	placebo	-
25 mcg/kg	placebo	-
20 mcg/kg	liraglutide	-
15 mcg/kg	liraglutide	-
25 mcg/kg	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Antibody against liraglutide
Adverse events
Body weight

Secondary Outcome Measures

Name	Time	Method
t½, terminal elimination half-life
Cmax, maximum concentration
tmax, time to reach Cmax
24-hour profiles of plasma glucose
Area under the plasma liraglutide concentration curve
Terminal elimination rate constant
24-hour profiles of serum insulin

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan