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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014