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

March 25, 2015 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NNC 90-1170
Drug: liraglutide
Single dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data
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
Drug: liraglutide
24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation
Other Names:
  • NNC 90-1170
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, 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
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
Drug: liraglutide
24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation
Other Names:
  • NNC 90-1170
Experimental: NNC 90-1170, final dose
Drug: liraglutide
Single dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data
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
Drug: liraglutide
24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation
Other Names:
  • NNC 90-1170

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ratio of the areas under the plasma NN 90-1170 curves

Secondary Outcome Measures

Outcome Measure
Mean residence time (MRT)
Adverse events
Area under the curve
Terminal rate constant
The maximum concentration (Cmax)
The time to maximum concentration (tmax)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

December 1, 2001

Study Completion (Actual)

December 1, 2001

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 17, 2012

First Posted (Estimate)

January 18, 2012

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-1464

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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