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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01511159
First received: January 12, 2012
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Diabetes
Healthy
Drug: NNC 90-1170
Drug: placebo
Drug: insulin human
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Ratio of the areas under the plasma NN 90-1170 curves [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The maximum concentration (Cmax) [ Designated as safety issue: No ]
  • The time to maximum concentration (tmax) [ Designated as safety issue: No ]
  • Mean residence time (MRT) [ Designated as safety issue: No ]
  • Area under the curve [ Designated as safety issue: No ]
  • Terminal rate constant [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: October 2001
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC 90-1170, initial dose Drug: NNC 90-1170
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: NNC 90-1170
Single dose of 12 mcg/kg by inhalation. Subjects receive treatment in random order
Drug: NNC 90-1170
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: NNC 90-1170
24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511159

Locations
United Kingdom
Tranent, United Kingdom, EH33 2NE
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Birgitte Scharling Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01511159     History of Changes
Other Study ID Numbers: NN2211-1464
Study First Received: January 12, 2012
Last Updated: August 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014