Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: liraglutide; Drug: placebo

• Registration Number: NCT01620476
• 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 liraglutide in healthy Japanese male subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• 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
• Body mass index (BMI) between 18 and 27 kg/m^2 inclusive

Exclusion Criteria

• Any clinical laboratory values deviated from the reference range at the laboratory
• 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
• Smokes more than 15 cigarettes, or the equivalent, per day andis unwilling to refrain from smoking whenever required for the trial procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 mcg/kg	placebo	-
10 mcg/kg	placebo	-
15 mcg/kg	placebo	-
5 mcg/kg	liraglutide	-
10 mcg/kg	liraglutide	-
15 mcg/kg	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma liraglutide curve

Secondary Outcome Measures

Name	Time	Method
Cmax, maximum plasma liraglutide concentration
tmax, time to reach Cmax
Terminal phase elimination rate-constant
24-hour profiles of serum glucose
t½, terminal elimination half life
24-hour profiles of serum insulin
24-hour profiles of plasma glucagon
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan