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

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ClinicalTrials.gov Identifier: NCT01511159
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: liraglutide Drug: placebo Drug: insulin human Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2001
Primary Completion Date : December 2001
Study Completion Date : December 2001
Arms and Interventions

Arm Intervention/treatment
Experimental: NNC 90-1170, initial dose Drug: liraglutide
Single dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data
Drug: placebo
Single dose by inhalation. Progression to open-label trial part will be based on safety data
Experimental: NNC 90-1170 Drug: liraglutide
Single dose of 12 mcg/kg by inhalation. Subjects receive treatment in random order
Drug: liraglutide
Single dose 6 mcg/kg injected subcutaneously. Subjects receive treatment in random order
Active Comparator: Insulin Drug: insulin human
Single dose 0.4 IU/kg by inhalation. Subjects receive treatment in random order
Drug: insulin human
Single dose 0.08 IU/kg injected subcutaneously. Subjects receive treatment in random order
Experimental: NNC 90-1170, final dose Drug: liraglutide
24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation
Other Name: NNC 90-1170


Outcome Measures

Primary Outcome Measures :
  1. Ratio of the areas under the plasma NN 90-1170 curves

Secondary Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511159


Locations
United Kingdom
Tranent, United Kingdom, EH33 2NE
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01511159     History of Changes
Other Study ID Numbers: NN2211-1464
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists