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

NCT01511159 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-03-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

liraglutide

Single dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data

DRUG

placebo

Single dose by inhalation. Progression to open-label trial part will be based on safety data

DRUG

liraglutide

Single dose of 12 mcg/kg by inhalation. Subjects receive treatment in random order

DRUG

liraglutide

Single dose 6 mcg/kg injected subcutaneously. Subjects receive treatment in random order

DRUG

insulin human

Single dose 0.4 IU/kg by inhalation. Subjects receive treatment in random order

DRUG

insulin human

Single dose 0.08 IU/kg injected subcutaneously. Subjects receive treatment in random order

DRUG

liraglutide

24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2001-12-31
Completion
2001-12-31

Countries

  • United Kingdom

Study Locations

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Entities

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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 NCT01511159 on ClinicalTrials.gov