Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers

Sponsor
Novo Nordisk A/S
Study ID
NCT01620476
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
MALE
Age
20 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • liraglutide — DRUG
    5 mcg/kg for 21 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data
  • liraglutide — DRUG
    5 mcg/kg for 7 days followed by 10 mcg/kg for 14 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data
  • liraglutide — DRUG
    5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days followed by 15 mcg/kg for 7 days. Injected subcutaneously once daily
  • placebo — DRUG
    Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Study Details

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.

Key Dates

Start date
Sep 30, 2003
Status verified
Jan 2017
Primary completion
Mar 31, 2004
Completion
Mar 31, 2004

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 5 mcg/kg
  • Experimental: 10 mcg/kg
  • Experimental: 15 mcg/kg

Primary Outcome Measure

Area under the plasma liraglutide curve

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