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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511159
• Other study ID #: NN2211-1464
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2012
• Last updated: March 25, 2015
• Start date: October 2001
• Est. completion date: December 2001

Study information

• Verified date: March 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2001
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of the areas under the plasma NN 90-1170 curves			No
Secondary	The maximum concentration (Cmax)			No
Secondary	The time to maximum concentration (tmax)			No
Secondary	Mean residence time (MRT)			No
Secondary	Area under the curve			No
Secondary	Terminal rate constant			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk