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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Terminated
CT.gov ID
NCT00523042
Collaborator
(none)
10
Enrollment
32
Locations
2
Arms
6
Actual Duration (Months)
0.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: insulin aspart
  • Drug: inhaled human insulin
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Aug 30, 2007
Actual Primary Completion Date :
Feb 28, 2008
Actual Study Completion Date :
Feb 28, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Active Comparator: B

Drug: insulin aspart
Treat-to-target dose titration scheme, injection s.c.
Other Names:
  • NovoRapid®
  • NovoLog®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in lung function, chest X-rays, or asthma exacerbation frequency [after 52 weeks of treatment]

    Secondary Outcome Measures

    1. Diabetes control measured by change in HbA1c [from baseline to end of treatment]

    2. Laboratory assessments (biochemistry, insulin antibodies, blood count) [from baseline to end of treatment]

    3. Preprandial insulin doses [for the duration of the trial]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Fresno California United States 93720
    2 Novo Nordisk Investigational Site New Orleans Louisiana United States 70112
    3 Novo Nordisk Investigational Site Kansas City Missouri United States 64108
    4 Novo Nordisk Investigational Site Columbus Ohio United States 43210
    5 Novo Nordisk Investigational Site Philadelphia Pennsylvania United States 19107
    6 Novo Nordisk Investigational Site Pittsburgh Pennsylvania United States 15213
    7 Novo Nordisk Investigational Site Houston Texas United States 77030
    8 Novo Nordisk Investigational Site Ogden Utah United States 84403
    9 Novo Nordisk Investigational Site Spokane Washington United States 99208
    10 Novo Nordisk Investigational Site Broadmeadow New South Wales Australia 2292
    11 Novo Nordisk Investigational Site Camperdown New South Wales Australia 2050
    12 Novo Nordisk Investigational Site Keswick South Australia Australia 5035
    13 Novo Nordisk Investigational Site Box Hill Victoria Australia 3128
    14 Novo Nordisk Investigational Site East Ringwood Victoria Australia 3135
    15 Novo Nordisk Investigational Site Parkville Victoria Australia 3052
    16 Novo Nordisk Investigational Site Auchenflower Australia 4066
    17 Novo Nordisk Investigational Site Kippa Ring Australia 4021
    18 Novo Nordisk Investigational Site Belgrade Former Serbia and Montenegro 11000
    19 Novo Nordisk Investigational Site Chandigarh Punjab India 160012
    20 Novo Nordisk Investigational Site Vellore Tamil Nadu India 632004
    21 Novo Nordisk Investigational Site Kolkata West Bengal India 700020
    22 Novo Nordisk Investigational Site Hyderabad India 600034
    23 Novo Nordisk Investigational Site Mumbai India 400 067
    24 Novo Nordisk Investigational Site Pune India 411011
    25 Novo Nordisk Investigational Site Cheras Malaysia 56000
    26 Novo Nordisk Investigational Site Kota Bharu, Kelantan Malaysia 16150
    27 Novo Nordisk Investigational Site Pulau Pinang Malaysia 10990
    28 Novo Nordisk Investigational Site Kosice Slovakia 04190
    29 Novo Nordisk Investigational Site Lubochna Slovakia 03491
    30 Novo Nordisk Investigational Site Moldava nad Bodvou Slovakia 045 01
    31 Novo Nordisk Investigational Site Zilina Slovakia 01001
    32 Novo Nordisk Investigational Site Zilina Slovakia 01207

    Sponsors and Collaborators

    • Novo Nordisk A/S

    Investigators

    • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT00523042
    Other Study ID Numbers:
    • NN1998-1616
    First Posted:
    Aug 30, 2007
    Last Update Posted:
    Sep 5, 2018
    Last Verified:
    Sep 1, 2018
    Additional relevant MeSH terms:
    Asthma
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Diabetes Mellitus, Type 1
    Insulin
    Insulin, Globin Zinc
    Insulin Aspart

    Study Results

    No Results Posted as of Sep 5, 2018