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Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers

NCT01515592 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-01-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

liraglutide

One daily subcutaneous dose for 5 weeks. Dose is weekly incremented with 5 mcg/kg

DRUG

liraglutide

One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg the third week, and finally 20 mcg for 2 weeks

DRUG

liraglutide

One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg for 3 weeks

DRUG

placebo

Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2006-04-30
Completion
2006-04-30

Countries

  • Japan

Study Locations

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Entities

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01515592 on ClinicalTrials.gov