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

• Status: Completed
• Trial end date: 2001-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc; Liraglutide

Criteria

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