Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma (iINHALE 9)

September 3, 2018 updated by: Novo Nordisk A/S

Inhaled Preprandial Human Insulin With the AERx® iMS Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Asthma: A 52-week, Open-label, Multinational, Randomised, Parallel Trial to Investigate Long-term Safety

This trial is conducted in Europe, Asia, Oceania and the United States of America (USA).

This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

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

  • Australia
      • Auchenflower, Australia, 4066
        • Novo Nordisk Investigational Site
      • Kippa Ring, Australia, 4021
        • Novo Nordisk Investigational Site
    • New South Wales
      • Broadmeadow, New South Wales, Australia, 2292
        • Novo Nordisk Investigational Site
      • Camperdown, New South Wales, Australia, 2050
        • Novo Nordisk Investigational Site
    • South Australia
      • Keswick, South Australia, Australia, 5035
        • Novo Nordisk Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Novo Nordisk Investigational Site
      • East Ringwood, Victoria, Australia, 3135
        • Novo Nordisk Investigational Site
      • Parkville, Victoria, Australia, 3052
        • Novo Nordisk Investigational Site
  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro, 11000
        • Novo Nordisk Investigational Site
  • India
      • Hyderabad, India, 600034
        • Novo Nordisk Investigational Site
      • Mumbai, India, 400 067
        • Novo Nordisk Investigational Site
      • Pune, India, 411011
        • Novo Nordisk Investigational Site
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Novo Nordisk Investigational Site
  • Malaysia
      • Cheras, Malaysia, 56000
        • Novo Nordisk Investigational Site
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk Investigational Site
      • Pulau Pinang, Malaysia, 10990
        • Novo Nordisk Investigational Site
  • Slovakia
      • Kosice, Slovakia, 04190
        • Novo Nordisk Investigational Site
      • Lubochna, Slovakia, 03491
        • Novo Nordisk Investigational Site
      • Moldava nad Bodvou, Slovakia, 045 01
        • Novo Nordisk Investigational Site
      • Zilina, Slovakia, 01001
        • Novo Nordisk Investigational Site
      • Zilina, Slovakia, 01207
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Novo Nordisk Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Novo Nordisk Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
    • Utah
      • Ogden, Utah, United States, 84403
        • Novo Nordisk Investigational Site
    • Washington
      • Spokane, Washington, United States, 99208
        • Novo Nordisk Investigational Site

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 or type 2 diabetes
  • Treatment with insulin and/or oral anti-diabetic drugs
  • Asthma for at least 6 months
  • Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years
  • HbA1C less than or equal to 11.0 %
  • Body Mass Index (BMI) less than or equal to 40.0 kg/m2

Exclusion Criteria:

  • Current smoking or smoking within the last 6 months
  • Other current acute or chronic pulmonary disease excluding asthma
  • Recurrent severe hypoglycaemia
  • Proliferative retinopathy or maculopathy

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: insulin aspart
Treat-to-target dose titration scheme, injection s.c.
Other Names:
  • NovoRapid®
  • NovoLog®
Experimental: A
Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in lung function, chest X-rays, or asthma exacerbation frequency
Time Frame: after 52 weeks of treatment
after 52 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Diabetes control measured by change in HbA1c
Time Frame: from baseline to end of treatment
from baseline to end of treatment
Laboratory assessments (biochemistry, insulin antibodies, blood count)
Time Frame: from baseline to end of treatment
from baseline to end of treatment
Preprandial insulin doses
Time Frame: for the duration of the trial
for the duration of the trial

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 (Actual)

August 30, 2007

Primary Completion (Actual)

February 28, 2008

Study Completion (Actual)

February 28, 2008

Study Registration Dates

First Submitted

August 29, 2007

First Submitted That Met QC Criteria

August 29, 2007

First Posted (Estimate)

August 30, 2007

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 3, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1998-1616

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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