Safety and Tolerability of Liraglutide in Japanese Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT01615978
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    5 mcg/kg daily for 14 days. Injected subcutaneously once daily
  • liraglutide — DRUG
    Initial dose of 5 mcg/kg for 7 days followed by 10 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 after multiple s.c. (subcutaneously) doses of liraglutide in Japanese subjects with type 2 diabetes.

Key Dates

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

Study Design

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

Arms

  • Experimental: Fixed dose: 5 mcg/kg
  • Experimental: Escalated dose: 10 mcg/kg

Primary Outcome Measure

24-hour profiles of serum calcitonin

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