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

A Single-Centre, Open-Label, Five-Period Crossover Trial In Healthy Male Volunteers Investigating the Relative Bioavailability of NNC 90-1170 By Pulmonary Administration Compared To A Subcutaneous Injection

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01511159

Enrollment

Registered

2012-01-18

Start date

2001-10-31

Completion date

2001-12-31

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

Brief 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.

Interventions

DRUGliraglutide

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

DRUGplacebo

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

DRUGinsulin human

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* No clinically important abnormal physical findings * No clinically relevant abnormalities in the results of laboratory screening evaluation * Normal (or abnormal but not clinically significant) ECG (electrocardiogram) * Normal (or abnormal but not clinically significant) blood pressure and heart rate * Body Mass Index (BMI) between 20-30 kg/m\^2 or outwith range but not clinically significant * Non-smoker * Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) at least 85% of predicted normal for age, gender and height * FVC ratio at least 75% of predicted normal for age, gender and height

Exclusion criteria

* A clinically significant illness or infection requiring treatment within the last two months * Any infection involving the respiratory system or adverse event that may, in the opinion of the principal investigator, interfere with blood glucose homeostasis * Subjects with first and/or second degree relative(s) with diabetes mellitus * Donation or loss of greater than 500 ml of blood in the period 0-12 weeks before trial entry * Alcohol use in excess of 28 units of alcohol per week. A unit of alcohol is equivalent to half a pint of average strength beer, a glass (125 ml) of wine or a pub measure (25 ml) of spirits, sherry or port * Current addiction to alcohol or substances of abuse * Females * Presence of hepatitis B surface antigen, hepatitis C antibody or HIV (human immunodeficiency virus) 1 or 2 antibodies

Design outcomes

Primary

Measure	Time frame
Ratio of the areas under the plasma NN 90-1170 curves	—

Secondary

Measure	Time frame
The time to maximum concentration (tmax)	—
Mean residence time (MRT)	—
The maximum concentration (Cmax)	—
Terminal rate constant	—
Adverse events	—
Area under the curve	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026