Skip to main content
OpenTrials
Completed

NCT Number: NCT01511159

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Tranent, EH33 2NE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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

Placebo

Drug

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

insulin human

Drug

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

Primary outcomes

  1. Ratio of the areas under the plasma NN 90-1170 curves

Secondary outcomes

  1. The maximum concentration (Cmax)

  2. The time to maximum concentration (tmax)

  3. Mean residence time (MRT)

  4. Area under the curve

  5. Terminal rate constant

  6. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Jan 18, 2012
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.