NCT01511159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Oct 2001

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

2 months

First QC Date

January 12, 2012

Last Update Submit

March 25, 2015

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • Ratio of the areas under the plasma NN 90-1170 curves

Secondary Outcomes (6)

  • The maximum concentration (Cmax)

  • The time to maximum concentration (tmax)

  • Mean residence time (MRT)

  • Area under the curve

  • Terminal rate constant

  • +1 more secondary outcomes

Study Arms (4)

NNC 90-1170, initial dose

EXPERIMENTAL
Drug: liraglutideDrug: placebo

NNC 90-1170

EXPERIMENTAL
Drug: liraglutide

Insulin

ACTIVE COMPARATOR
Drug: insulin human

NNC 90-1170, final dose

EXPERIMENTAL
Drug: liraglutide

Interventions

liraglutideDRUG

Single dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data

NNC 90-1170, initial dose
placeboDRUG

Single dose by inhalation. Progression to open-label trial part will be based on safety data

NNC 90-1170, initial dose
insulin humanDRUG

Single dose 0.4 IU/kg by inhalation. Subjects receive treatment in random order

Insulin

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tranent, EH33 2NE, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

LiraglutideInsulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProinsulinInsulinsPancreatic HormonesPeptide HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 18, 2012

Study Start

October 1, 2001

Primary Completion

December 1, 2001

Study Completion

December 1, 2001

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

GB(1)