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Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Terminated
CT.gov ID
NCT00322257
Collaborator
(none)
596
Enrollment
96
Locations
2
Arms
23.1
Actual Duration (Months)
6.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 Diabetes.

Condition or Disease Intervention/Treatment Phase
  • Drug: inhaled human insulin
  • Drug: insulin detemir
  • 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 :
596 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Inhaled Mealtime Insulin With the AERx® iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Parallel Trial (Followed by a Twelve-Week Re-Randomised Extension) To Investigate Safety and Efficacy
Actual Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Apr 2, 2008
Actual Study Completion Date :
Apr 2, 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:
  • Levemir, NN304

    		•
    Active Comparator: B

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

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

    Outcome Measures

    Primary Outcome Measures

    1. HbA1c [After 52 weeks]

    Secondary Outcome Measures

    1. Body weight [after 52 weeks]

    2. Antibodies [after 52 weeks]

    3. Hypoglycemia [For the duration of the trial]

    4. Insulin doses [For the duration of the trial]

    5. Pulmonary Function [For the duration of the trial]

    6. Fasting plasma glucose [after 52 weeks]

    Eligibility Criteria

    Criteria

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

    • Type 1 diabetes

    • HbA1c less than or equal to 11%

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

    Exclusion Criteria:

    • Total daily insulin dosage more than 100 IU or U/day.

    • Current smoking or smoking within the last 6 months

    • Impaired hepatic or renal function

    • Cardiac problems

    • Uncontrolled hypertension

    • Current proliferative retinopathy or maculopathy requiring acute treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Birmingham Alabama United States 35294
    2 Novo Nordisk Investigational Site Tuscaloosa Alabama United States 35406
    3 Novo Nordisk Investigational Site Concord California United States 94520
    4 Novo Nordisk Investigational Site Encino California United States 91436
    5 Novo Nordisk Investigational Site Escondido California United States 92025
    6 Novo Nordisk Investigational Site Fresno California United States 93720
    7 Novo Nordisk Investigational Site Inglewood California United States 90301
    8 Novo Nordisk Investigational Site La Jolla California United States 92037
    9 Novo Nordisk Investigational Site Mission Viejo California United States 92691
    10 Novo Nordisk Investigational Site Poway California United States 92064
    11 Novo Nordisk Investigational Site San Mateo California United States 94401
    12 Novo Nordisk Investigational Site Santa Barbara California United States 93105
    13 Novo Nordisk Investigational Site Tustin California United States 92780
    14 Novo Nordisk Investigational Site Vista California United States 92084
    15 Novo Nordisk Investigational Site Walnut Creek California United States 94598
    16 Novo Nordisk Investigational Site Aurora Colorado United States 80045
    17 Novo Nordisk Investigational Site Colorado Springs Colorado United States 80909
    18 Novo Nordisk Investigational Site New Britain Connecticut United States 06050
    19 Novo Nordisk Investigational Site Norwalk Connecticut United States 06851
    20 Novo Nordisk Investigational Site Waterbury Connecticut United States 06708
    21 Novo Nordisk Investigational Site Boca Raton Florida United States 33433
    22 Novo Nordisk Investigational Site Hollywood Florida United States 33021
    23 Novo Nordisk Investigational Site Lake Mary Florida United States 32746
    24 Novo Nordisk Investigational Site Melbourne Florida United States 32901
    25 Novo Nordisk Investigational Site Merritt Island Florida United States 32953
    26 Novo Nordisk Investigational Site Miami Florida United States 33136
    27 Novo Nordisk Investigational Site West Palm Beach Florida United States 33401
    28 Novo Nordisk Investigational Site Athens Georgia United States 30606
    29 Novo Nordisk Investigational Site Atlanta Georgia United States 30318
    30 Novo Nordisk Investigational Site Savannah Georgia United States 31406
    31 Novo Nordisk Investigational Site Honolulu Hawaii United States 96813
    32 Novo Nordisk Investigational Site Honolulu Hawaii United States 96814
    33 Novo Nordisk Investigational Site Idaho Falls Idaho United States 83404-7596
    34 Novo Nordisk Investigational Site Chicago Illinois United States 60607
    35 Novo Nordisk Investigational Site Peoria Illinois United States 61615
    36 Novo Nordisk Investigational Site Springfield Illinois United States 62711
    37 Novo Nordisk Investigational Site Lafayette Indiana United States 47904
    38 Novo Nordisk Investigational Site New Albany Indiana United States 47150
    39 Novo Nordisk Investigational Site Des Moines Iowa United States 50314
    40 Novo Nordisk Investigational Site Shawnee Mission Kansas United States 66204
    41 Novo Nordisk Investigational Site Topeka Kansas United States 66606
    42 Novo Nordisk Investigational Site Lexington Kentucky United States 40503
    43 Novo Nordisk Investigational Site Baton Rouge Louisiana United States 70808
    44 Novo Nordisk Investigational Site Scarborough Maine United States 04074
    45 Novo Nordisk Investigational Site Hyattsville Maryland United States 20782
    46 Novo Nordisk Investigational Site Springfield Massachusetts United States 01199
    47 Novo Nordisk Investigational Site Waltham Massachusetts United States 02453
    48 Novo Nordisk Investigational Site Bloomington Minnesota United States 55420
    49 Novo Nordisk Investigational Site Duluth Minnesota United States 55805
    50 Novo Nordisk Investigational Site Minneapolis Minnesota United States 55416-2699
    51 Novo Nordisk Investigational Site Tupelo Mississippi United States 38801
    52 Novo Nordisk Investigational Site Jefferson City Missouri United States 65109
    53 Novo Nordisk Investigational Site Kansas City Missouri United States 64114
    54 Novo Nordisk Investigational Site Saint Louis Missouri United States 63141
    55 Novo Nordisk Investigational Site Butte Montana United States 59701
    56 Novo Nordisk Investigational Site Omaha Nebraska United States 68114
    57 Novo Nordisk Investigational Site Dover New Hampshire United States 03820
    58 Novo Nordisk Investigational Site Hampton New Hampshire United States 03842
    59 Novo Nordisk Investigational Site Lawrenceville New Jersey United States 08648
    60 Novo Nordisk Investigational Site Albany New York United States 12206
    61 Novo Nordisk Investigational Site New Hyde Park New York United States 11042
    62 Novo Nordisk Investigational Site Rochester New York United States 14642
    63 Novo Nordisk Investigational Site Asheville North Carolina United States 28803
    64 Novo Nordisk Investigational Site Greenville North Carolina United States 27834
    65 Novo Nordisk Investigational Site Cincinnati Ohio United States 45267
    66 Novo Nordisk Investigational Site Cleveland Ohio United States 44122
    67 Novo Nordisk Investigational Site Dayton Ohio United States 45406
    68 Novo Nordisk Investigational Site Kettering Ohio United States 45429
    69 Novo Nordisk Investigational Site Mentor Ohio United States 44060
    70 Novo Nordisk Investigational Site Medford Oregon United States 97504
    71 Novo Nordisk Investigational Site Hershey Pennsylvania United States 17033
    72 Novo Nordisk Investigational Site Norristown Pennsylvania United States 19401
    73 Novo Nordisk Investigational Site Philadelphia Pennsylvania United States 19107
    74 Novo Nordisk Investigational Site Chattanooga Tennessee United States 37404
    75 Novo Nordisk Investigational Site Chattanooga Tennessee United States 37411
    76 Novo Nordisk Investigational Site Dallas Texas United States 75230
    77 Novo Nordisk Investigational Site Dallas Texas United States 75231
    78 Novo Nordisk Investigational Site Dallas Texas United States 75246
    79 Novo Nordisk Investigational Site Dallas Texas United States 75390-8858
    80 Novo Nordisk Investigational Site Midland Texas United States 79707
    81 Novo Nordisk Investigational Site San Antonio Texas United States 78229
    82 Novo Nordisk Investigational Site Ogden Utah United States 84403
    83 Novo Nordisk Investigational Site Olympia Washington United States 98502
    84 Novo Nordisk Investigational Site Renton Washington United States 98057
    85 Novo Nordisk Investigational Site Spokane Washington United States 99208
    86 Novo Nordisk Investigational Site Milwaukee Wisconsin United States 53209
    87 Novo Nordisk Investigational Site Victoria British Columbia Canada V8R 1J8
    88 Novo Nordisk Investigational Site Winnipeg Manitoba Canada R3E 3P4
    89 Novo Nordisk Investigational Site Laval Quebec Canada H7T 2P5
    90 Novo Nordisk Investigational Site Montreal Quebec Canada H2W 1T8
    91 Novo Nordisk Investigational Site Gatineau Canada J8T 8M1
    92 Novo Nordisk Investigational Site Mississauga Canada L5M 2V8
    93 Novo Nordisk Investigational Site Penticton Canada V2A 5C8
    94 Novo Nordisk Investigational Site Red Deer Canada T4N 6V7
    95 Novo Nordisk Investigational Site St John's Canada A1B 3V6
    96 Novo Nordisk Investigational Site Vancouver Canada V5Z 1C6

    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:
    NCT00322257
    Other Study ID Numbers:
    • NN1998-2076
    First Posted:
    May 5, 2006
    Last Update Posted:
    Sep 5, 2018
    Last Verified:
    Sep 1, 2018
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1
    Insulin
    Insulin, Globin Zinc
    Insulin Aspart
    Insulin Detemir

    Study Results

    No Results Posted as of Sep 5, 2018