To Investigate the Blood Concentration of Liraglutide as Well as the Effects on Glucose and Insulin After 21 Days of Daily Subcutaneous Injections of Liraglutide or Placebo

Sponsor
Novo Nordisk A/S
Study ID
NCT00761540
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • liraglutide — DRUG
    Liraglutide for s.c. injection once daily: dose step 1 (9 subjects)
  • placebo — DRUG
    Liraglutide placebo for s.c. injection once daily: dose step 1 (3 subjects)
  • liraglutide — DRUG
    Liraglutide for s.c. injection once daily: dose step 1, followed by dose step 2 (9 subjects)
  • placebo — DRUG
    Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose step 2 (3 subjects)
  • liraglutide — DRUG
    Liraglutide for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (9 subjects)
  • placebo — DRUG
    Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (3 subjects)

Study Details

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin (pharmacodynamics) after 21 days of daily subcutaneous injections (injected under the skin) of liraglutide or placebo. In addition, the safety and tolerability of liraglutide will be observed.

Key Dates

Start date
Oct 31, 2008
Status verified
Jan 2017
Primary completion
Dec 31, 2008
Completion
Dec 31, 2008

Study Design

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

Arms

  • Experimental: A1
  • Placebo Comparator: A2
  • Experimental: B1
  • Placebo Comparator: B2
  • Experimental: C1
  • Placebo Comparator: C2

Primary Outcome Measure

AUC 0-24h (last dosing day): Area under the plasma liraglutide curve from 0 to 24 hours after last dosing. [ Time Frame: After 21 days of treatment ]

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