Comparison of Liraglutide Inhaled Into the Lungs Compared to Liraglutide Injected Under the Skin in Healthy Male Volunteers

Sponsor
Novo Nordisk A/S
Study ID
NCT01511159
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    Single dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data
  • placebo — DRUG
    Single dose by inhalation. Progression to open-label trial part will be based on safety data
  • liraglutide — DRUG
    Single dose of 12 mcg/kg by inhalation. Subjects receive treatment in random order
  • liraglutide — DRUG
    Single dose 6 mcg/kg injected subcutaneously. Subjects receive treatment in random order
  • insulin human — DRUG
    Single dose 0.4 IU/kg by inhalation. Subjects receive treatment in random order
  • insulin human — DRUG
    Single dose 0.08 IU/kg injected subcutaneously. Subjects receive treatment in random order
  • liraglutide — DRUG
    24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation

Study Details

This trial is conducted in Europe. The aim of this trial is to determine the relative bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when injected under the skin.

Key Dates

Start date
Oct 31, 2001
Status verified
Mar 2015
Primary completion
Dec 31, 2001
Completion
Dec 31, 2001

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: NNC 90-1170, initial dose
  • Experimental: NNC 90-1170
  • Active Comparator: Insulin
  • Experimental: NNC 90-1170, final dose

Primary Outcome Measure

Ratio of the areas under the plasma NN 90-1170 curves

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