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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: liraglutide; Drug: insulin human; Drug: placebo

• Registration Number: NCT01511159
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2001-12
• Study Completion: 2001-12
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-18
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NNC 90-1170, initial dose	liraglutide	-
NNC 90-1170, initial dose	placebo	-
Insulin	insulin human	-
NNC 90-1170	liraglutide	-
NNC 90-1170, final dose	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Ratio of the areas under the plasma NN 90-1170 curves

Secondary Outcome Measures

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