Comparison of Liraglutide Inhaled Into the Lungs Compared to Liraglutide Injected Under the Skin in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- DiabetesHealthy
- Interventions
- 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
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 Area under the curve Mean residence time (MRT) The time to maximum concentration (tmax) Adverse events The maximum concentration (Cmax)