Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes



Status:Terminated
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:9/7/2018
Start Date:May 1, 2006
End Date:April 2, 2008

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Trial Summary
Trial Overview
Inclusion Criteria

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.

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.

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
We found this trial at
82
sites
Novo Nordisk Investigational Site
San Antonio, Texas 78224
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Albany, New York 12208
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Asheville, North Carolina 28801
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Athens, Georgia 30606
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Athens, GA
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Atlanta, Georgia 30318
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Aurora, Colorado 80010
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Baton Rouge, Louisiana 70808
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Novo Nordisk Investigational Site
Birmingham, Alabama 35215
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Novo Nordisk Investigational Site
Bloomington, Minnesota 55420
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Boca Raton, Florida 33433
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Boca Raton, FL
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Butte, Montana 59701
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Chattanooga, Tennessee 37404
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Novo Nordisk Investigational Site
Chicago, Illinois 60612
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Chicago, IL
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Novo Nordisk Investigational Site
Cincinnati, Ohio 45229
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Cincinnati, OH
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Cleveland, Ohio 44106
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Colorado Springs, Colorado 80910
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Novo Nordisk Investigational Site
Concord, California 94520
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Dallas, Texas 75231
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Dayton, Ohio 45406
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Des Moines, Iowa 50314
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Dover, New Hampshire 03820
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Duluth, Minnesota 55805
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Encino, California 91436
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Encino, CA
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Escondido, California 92025
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Fresno, California 93702
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Greenville, North Carolina 27834
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Hampton, New Hampshire 03842
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Hershey, Pennsylvania 17033
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Hollywood, Florida 33024
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Honolulu, Hawaii 96814
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Honolulu, HI
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Hyattsville, Maryland 20782
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Idaho Falls, Idaho 83404
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Inglewood, California 90301
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Jefferson City, Missouri 65109
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Kansas City, Missouri 64106
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Kettering, Ohio 45429
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La Jolla, California 92037
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Lafayette, Indiana 47904
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Lafayette, IN
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Lake Mary, Florida 32746
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Lawrenceville, New Jersey 08648
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Lexington, Kentucky 40503
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Medford, Oregon 97501
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Melbourne, Florida 32901
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Mentor, Ohio 44060
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Merritt Island, Florida 32953
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Miami, Florida 33136
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Midland, Texas 79707
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Milwaukee, Wisconsin 53209
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Minneapolis, Minnesota 55404
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Mission Viejo, California 92691
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New Albany, Indiana 47150
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New Britain, Connecticut 06050
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New Hyde Park, New York 11042
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Norristown, Pennsylvania 19401
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Norwalk, Connecticut 06851
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Ogden, Utah 84405
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Olympia, Washington 98502
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Omaha, Nebraska 68114
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Peoria, Illinois 61615
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Philadelphia, Pennsylvania 19104
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Poway, California 92064
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Renton, Washington 98057
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Rochester, New York 14609
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Saint Louis, Missouri 63110
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San Mateo, California 94401
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Santa Barbara, California 93105
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Savannah, Georgia 31406
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Scarborough, Maine 04074
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Shawnee Mission, Kansas 66204
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Spokane, Washington 99202
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Springfield, Illinois 62702
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Springfield, Massachusetts 01107
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Topeka, Kansas 66606
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Tupelo, Mississippi 38801
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Tuscaloosa, Alabama 35406
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Tustin, California 92780
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Victoria, British Columbia
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Vista, California 92083
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Walnut Creek, California 94598
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Waltham, Massachusetts 02453
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Waterbury, Connecticut 06708
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West Palm Beach, Florida 33409
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