Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

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

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

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.

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)

596

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

  • Canada
      • Gatineau, Canada, J8T 8M1
        • Novo Nordisk Investigational Site
      • Mississauga, Canada, L5M 2V8
        • Novo Nordisk Investigational Site
      • Penticton, Canada, V2A 5C8
        • Novo Nordisk Investigational Site
      • Red Deer, Canada, T4N 6V7
        • Novo Nordisk Investigational Site
      • St John's, Canada, A1B 3V6
        • Novo Nordisk Investigational Site
      • Vancouver, Canada, V5Z 1C6
        • Novo Nordisk Investigational Site
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Novo Nordisk Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Novo Nordisk Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Novo Nordisk Investigational Site
      • Montreal, Quebec, Canada, H2W 1T8
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Novo Nordisk Investigational Site
      • Tuscaloosa, Alabama, United States, 35406
        • Novo Nordisk Investigational Site
    • California
      • Concord, California, United States, 94520
        • Novo Nordisk Investigational Site
      • Encino, California, United States, 91436
        • Novo Nordisk Investigational Site
      • Escondido, California, United States, 92025
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Inglewood, California, United States, 90301
        • Novo Nordisk Investigational Site
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
      • Mission Viejo, California, United States, 92691
        • Novo Nordisk Investigational Site
      • Poway, California, United States, 92064
        • Novo Nordisk Investigational Site
      • San Mateo, California, United States, 94401
        • Novo Nordisk Investigational Site
      • Santa Barbara, California, United States, 93105
        • Novo Nordisk Investigational Site
      • Tustin, California, United States, 92780
        • Novo Nordisk Investigational Site
      • Vista, California, United States, 92084
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novo Nordisk Investigational Site
      • Colorado Springs, Colorado, United States, 80909
        • Novo Nordisk Investigational Site
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • Novo Nordisk Investigational Site
      • Norwalk, Connecticut, United States, 06851
        • Novo Nordisk Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • Novo Nordisk Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33433
        • Novo Nordisk Investigational Site
      • Hollywood, Florida, United States, 33021
        • Novo Nordisk Investigational Site
      • Lake Mary, Florida, United States, 32746
        • Novo Nordisk Investigational Site
      • Melbourne, Florida, United States, 32901
        • Novo Nordisk Investigational Site
      • Merritt Island, Florida, United States, 32953
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33136
        • Novo Nordisk Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Novo Nordisk Investigational Site
    • Georgia
      • Athens, Georgia, United States, 30606
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
      • Savannah, Georgia, United States, 31406
        • Novo Nordisk Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novo Nordisk Investigational Site
      • Honolulu, Hawaii, United States, 96813
        • Novo Nordisk Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
      • Peoria, Illinois, United States, 61615
        • Novo Nordisk Investigational Site
      • Springfield, Illinois, United States, 62711
        • Novo Nordisk Investigational Site
    • Indiana
      • Lafayette, Indiana, United States, 47904
        • Novo Nordisk Investigational Site
      • New Albany, Indiana, United States, 47150
        • Novo Nordisk Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Novo Nordisk Investigational Site
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Novo Nordisk Investigational Site
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Novo Nordisk Investigational Site
    • Maine
      • Scarborough, Maine, United States, 04074
        • Novo Nordisk Investigational Site
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Novo Nordisk Investigational Site
      • Waltham, Massachusetts, United States, 02453
        • Novo Nordisk Investigational Site
    • Minnesota
      • Bloomington, Minnesota, United States, 55420
        • Novo Nordisk Investigational Site
      • Duluth, Minnesota, United States, 55805
        • Novo Nordisk Investigational Site
      • Minneapolis, Minnesota, United States, 55416-2699
        • Novo Nordisk Investigational Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Novo Nordisk Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Novo Nordisk Investigational Site
      • Kansas City, Missouri, United States, 64114
        • Novo Nordisk Investigational Site
      • Saint Louis, Missouri, United States, 63141
        • Novo Nordisk Investigational Site
    • Montana
      • Butte, Montana, United States, 59701
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Dover, New Hampshire, United States, 03820
        • Novo Nordisk Investigational Site
      • Hampton, New Hampshire, United States, 03842
        • Novo Nordisk Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Novo Nordisk Investigational Site
      • New Hyde Park, New York, United States, 11042
        • Novo Nordisk Investigational Site
      • Rochester, New York, United States, 14642
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Novo Nordisk Investigational Site
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45406
        • Novo Nordisk Investigational Site
      • Kettering, Ohio, United States, 45429
        • Novo Nordisk Investigational Site
      • Mentor, Ohio, United States, 44060
        • Novo Nordisk Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Novo Nordisk Investigational Site
      • Norristown, Pennsylvania, United States, 19401
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-8858
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Midland, Texas, United States, 79707
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
    • Utah
      • Ogden, Utah, United States, 84403
        • Novo Nordisk Investigational Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Novo Nordisk Investigational Site
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99208
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • 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 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: After 52 weeks
After 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: after 52 weeks
after 52 weeks
Antibodies
Time Frame: after 52 weeks
after 52 weeks
Hypoglycemia
Time Frame: For the duration of the trial
For the duration of the trial
Insulin doses
Time Frame: For the duration of the trial
For the duration of the trial
Pulmonary Function
Time Frame: For the duration of the trial
For the duration of the trial
Fasting plasma glucose
Time Frame: after 52 weeks
after 52 weeks

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)

May 1, 2006

Primary Completion (Actual)

April 2, 2008

Study Completion (Actual)

April 2, 2008

Study Registration Dates

First Submitted

May 3, 2006

First Submitted That Met QC Criteria

May 4, 2006

First Posted (Estimate)

May 5, 2006

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

  • NN1998-2076

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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