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Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Terminated
CT.gov ID
NCT00331604
Collaborator
(none)
618
Enrollment
73
Locations
3
Arms
20.1
Actual Duration (Months)
8.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.

Condition or Disease Intervention/Treatment Phase
  • Drug: inhaled human insulin
  • Drug: insulin detemir
  • Drug: insulin aspart
  • Drug: insulin aspart
 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 :
618 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Inhaled Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy
Actual Study Start Date :
Aug 31, 2006
Actual Primary Completion Date :
May 5, 2008
Actual Study Completion Date :
May 5, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

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

Drug: insulin detemir
Injection s.c., 50% of daily dose.
Other Names:
  • NN304
  • Levemir

    		•
    Active Comparator: B

    Drug: insulin detemir
    Injection s.c., 50% of daily dose.
    Other Names:
  • NN304
  • Levemir

    • Drug: insulin aspart
    Treat-to-target dose titration scheme, injection s.c.
    Active Comparator: C

    Drug: insulin detemir
    Injection s.c., 50% of daily dose.
    Other Names:
  • NN304
  • Levemir

    • Drug: insulin aspart
    Treat-to-target dose titration scheme, injection s.c.

    Drug: insulin aspart
    Treat-to-target dose titration scheme, injection s.c. After 2 years.

    Outcome Measures

    Primary Outcome Measures

    1. Treatment difference in HbA1c [After 52 weeks]

    Secondary Outcome Measures

    1. Adverse events [For the duration of the trial]

    2. Blood glucose [After 52, 104 and 116 weeks of treatment]

    3. Body weight [During treatment]

    4. Lung function [After 52, 104 and 116 weeks of treatment]

    5. Hypoglycaemia [From 12 weeks of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Type 2 diabetes

    • Currently treated with insulin

    • Body mass index of (BMI) less than or equal to 40.0 kg/m2

    • HbA1c less than or equal to 11.0%

    Exclusion Criteria:

    • Total daily insulin dosage less than or equal to 100 IU or U/day

    • Current smoking or smoking within the last 6 months

    • Cardiac problems

    • Uncontrolled hypertension

    • Current proliferative retinopathy or maculopathy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Campinas Brazil 13083-900
    2 Novo Nordisk Investigational Site Higienopolis Brazil 01244-030
    3 Novo Nordisk Investigational Site Porto Alegre Brazil 90035-170
    4 Novo Nordisk Investigational Site Sao Paulo Brazil 04022-001
    5 Novo Nordisk Investigational Site Hillerød Denmark 3400
    6 Novo Nordisk Investigational Site Hvidovre Denmark 2650
    7 Novo Nordisk Investigational Site Århus C Denmark 8000
    8 Novo Nordisk Investigational Site Brest France 29200
    9 Novo Nordisk Investigational Site GRENOBLE cedex France 38043
    10 Novo Nordisk Investigational Site LA ROCHELLE cedex France 17019
    11 Novo Nordisk Investigational Site Nanterre France 92014
    12 Novo Nordisk Investigational Site Narbonne France 11108
    13 Novo Nordisk Investigational Site NEVERS cedex France 58033
    14 Novo Nordisk Investigational Site Strasbourg France 67091
    15 Novo Nordisk Investigational Site TOULOUSE cedex France 31054
    16 Novo Nordisk Investigational Site Bad Harzburg Germany 38667
    17 Novo Nordisk Investigational Site Bad Kreuznach Germany 55545
    18 Novo Nordisk Investigational Site Bad Lauterberg Germany 37431
    19 Novo Nordisk Investigational Site Dresden Germany 01219
    20 Novo Nordisk Investigational Site Dresden Germany 01307
    21 Novo Nordisk Investigational Site Friedrichsthal Germany 66299
    22 Novo Nordisk Investigational Site Hamburg Germany 21073
    23 Novo Nordisk Investigational Site Hamburg Germany 22607
    24 Novo Nordisk Investigational Site Herrenberg Germany 71083
    25 Novo Nordisk Investigational Site Hohenmölsen Germany 06679
    26 Novo Nordisk Investigational Site Neumünster Germany 24534
    27 Novo Nordisk Investigational Site Neuwied Germany 56564
    28 Novo Nordisk Investigational Site Schkeuditz Germany 04435
    29 Novo Nordisk Investigational Site Speyer Germany 67346
    30 Novo Nordisk Investigational Site St. Ingbert Germany 66386
    31 Novo Nordisk Investigational Site Völklingen Germany 66333
    32 Novo Nordisk Investigational Site Warburg Germany 34414
    33 Novo Nordisk Investigational Site Shatin, New Territories Hong Kong
    34 Novo Nordisk Investigational Site Beer Sheva Israel 84101
    35 Novo Nordisk Investigational Site Holon Israel 58100
    36 Novo Nordisk Investigational Site Jerusalem Israel 91120
    37 Novo Nordisk Investigational Site Bari Italy 70124
    38 Novo Nordisk Investigational Site Catania Italy 95122
    39 Novo Nordisk Investigational Site Catanzaro Italy 88100
    40 Novo Nordisk Investigational Site Milano Italy 20132
    41 Novo Nordisk Investigational Site Perugia Italy 06126
    42 Novo Nordisk Investigational Site Pescara Italy 65124
    43 Novo Nordisk Investigational Site Pisa Italy 56100
    44 Novo Nordisk Investigational Site Roma Italy 00133
    45 Novo Nordisk Investigational Site Roma Italy 00168
    46 Novo Nordisk Investigational Site San Giovanni Rotondo Italy 71013
    47 Novo Nordisk Investigational Site Verona Italy 37126
    48 Novo Nordisk Investigational Site Singapore Singapore 119074
    49 Novo Nordisk Investigational Site Singapore Singapore 159964
    50 Novo Nordisk Investigational Site Almería Spain 04001
    51 Novo Nordisk Investigational Site Cáceres Spain 10004
    52 Novo Nordisk Investigational Site Elche Spain 3203
    53 Novo Nordisk Investigational Site Granada Spain 18012
    54 Novo Nordisk Investigational Site Lugo Spain 27004
    55 Novo Nordisk Investigational Site Mostoles - Madrid - Spain 28935
    56 Novo Nordisk Investigational Site Sevilla Spain 41014
    57 Novo Nordisk Investigational Site Valladolid Spain 47011
    58 Novo Nordisk Investigational Site Xátiva Spain 46800
    59 Novo Nordisk Investigational Site Taichung City Taiwan 407
    60 Novo Nordisk Investigational Site Taipei Taiwan 100
    61 Novo Nordisk Investigational Site Taipei Taiwan 114
    62 Novo Nordisk Investigational Site Aberdeen United Kingdom AB25 1LD
    63 Novo Nordisk Investigational Site Ayr United Kingdom KA6 6DX
    64 Novo Nordisk Investigational Site Bristol United Kingdom BS10 5NB
    65 Novo Nordisk Investigational Site Cosham United Kingdom PO6 3LY
    66 Novo Nordisk Investigational Site Edgbaston, Birmingham United Kingdom B15 2TH
    67 Novo Nordisk Investigational Site Edinburgh United Kingdom EH16 4SA
    68 Novo Nordisk Investigational Site Livingstone United Kingdom EH54 6PP
    69 Novo Nordisk Investigational Site Nottingham United Kingdom NG7 2UH
    70 Novo Nordisk Investigational Site Plymouth United Kingdom PL6 8BQ
    71 Novo Nordisk Investigational Site Salford United Kingdom M6 8HD
    72 Novo Nordisk Investigational Site Sheffield United Kingdom S5 7AU
    73 Novo Nordisk Investigational Site Wirral, Merseyside United Kingdom CH63 4JY

    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:
    NCT00331604
    Other Study ID Numbers:
    • NN1998-2161
    • 2005-005378-58
    First Posted:
    May 31, 2006
    Last Update Posted:
    Mar 1, 2017
    Last Verified:
    Feb 1, 2017
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Insulin
    Insulin, Globin Zinc
    Insulin Aspart
    Insulin, Long-Acting
    Insulin degludec, insulin aspart drug combination
    Insulin Detemir

    Study Results

    No Results Posted as of Mar 1, 2017