Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: placebo; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01620476

NN2211-1551

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups

5 mcg/kg

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: placebo

Drug: liraglutide

10 mcg/kg

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: placebo

Drug: liraglutide

15 mcg/kg

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: placebo

Drug: liraglutide