Tranent, EH33 2NE, United Kingdom
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.
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
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
DrugSingle dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data
Placebo
DrugSingle dose by inhalation. Progression to open-label trial part will be based on safety data
insulin human
DrugSingle dose 0.4 IU/kg by inhalation. Subjects receive treatment in random order
Primary outcomes
-
Ratio of the areas under the plasma NN 90-1170 curves
Secondary outcomes
-
The maximum concentration (Cmax)
-
The time to maximum concentration (tmax)
-
Mean residence time (MRT)
-
Area under the curve
-
Terminal rate constant
-
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.
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