Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes



Status:Terminated
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:9/7/2018
Start Date:November 29, 2006
End Date:March 18, 2008

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Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes

This trial is conducted in the United States of America (USA). This trial will compare the
changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy
versus pioglitazone treatment alone.

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 2 diabetes

- Current treatment with oral antidiabetes drugs (OADs) for at least 2 months

- HbA1c between 7.0-11.0% if on OAD monotherapy

- HbA1c between 7.0-10.0% if on OAD combination therapy

- BMI less than or equal to 40 kg/m2

Exclusion Criteria:

- Current regular smoking or regular smoking within the last 6 months

- Current acute or chronic pulmonary disease (except for asthma)

- Proliferative retinopathy requiring treatment

- Clinically significant disease history including kidney or liver disease, or heart
disease which limits physical activity or results in discomfort with physical activity

- Pregnancy
We found this trial at
103
sites
Kingsport, Tennessee 37660
843
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Kingsport, TN
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Altoona, Pennsylvania 16602
1056
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Arlington, Texas 76012
347
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Arlington, Virginia 22206
1123
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Arvada, Colorado 80005
416
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Arvada, CO
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Athens, Georgia 30606
849
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Athens, GA
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Atlanta, Georgia 30318
801
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Atlanta, GA
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Avon, Illinois 46123
443
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Avon, IL
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Baltimore, Maryland 21229
1144
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Beaver, Pennsylvania 15009
957
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Bensalem, Pennsylvania 19020
1236
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Bermuda Dunes, California 92203
1069
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Beverly Hills, Florida 34465
1074
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Billings, Montana 59101
780
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Bismarck, North Dakota 58501
643
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Bismarck, ND
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Bloomington, Minnesota 55420
542
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Blue Ridge, Georgia 30513
776
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Boca Raton, Florida 33433
1299
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Boca Raton, FL
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1037
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Boise, ID
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Canal Fulton, Ohio 44614
892
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Canal Fulton, OH
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Charlotte, North Carolina 28277
957
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Chesterfield, Missouri 63017
398
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Chesterfield, MO
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Chicago, Illinois 60612
609
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Chicago, IL
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Cincinnati, Ohio 45229
727
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Clarksville, Tennessee 37043
582
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Clearwater, Florida 33756
1102
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Cleveland, Ohio 44106
894
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Clinton, Oklahoma 73601
166
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Clinton, OK
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Colorado Springs, Colorado 80910
383
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Colorado Springs, CO
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Dallas, Texas 75231
341
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744
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Dayton, OH
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Des Moines, Iowa 50314
347
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Dunwoody, Georgia 30338
798
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Dunwoody, GA
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Escondido, California 92025
1128
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Escondido, CA
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Fresno, California 93702
1205
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Greer, South Carolina 29651
888
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Hershey, Pennsylvania 17033
1147
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Hershey, PA
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Hialeah, Florida 33012
1313
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High Point, North Carolina 27265
853
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Hollywood, Florida 33024
1312
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Honolulu, Hawaii 96814
3717
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Houston, Texas 77030
572
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Houston, TX
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Huntington Beach, California 92648
1164
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Jackson, Mississippi 39209
572
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Jefferson City, Missouri 65109
312
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Kansas City, Missouri 64106
199
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La Jolla, California 92037
1145
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Lafayette, Indiana 47904
614
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Lafayette, IN
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Lake Mary, Florida 32746
1135
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Las Vegas, Nevada 89128
967
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Lewisville, Texas 75067
328
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Lexington, Kentucky 40503
724
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Little Rock, Arkansas 72202
371
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Little Rock, AR
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Marianna, Florida 32446
864
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Marianna, FL
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Marlborough, Massachusetts 01752
1419
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Medford, Oregon 97501
1357
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Melbourne, Florida 32901
1198
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Miami, Florida 33136
1320
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Niceville, Florida 32578
817
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Norfolk, Virginia 23510
1182
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Norristown, Pennsylvania 19401
1215
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Northridge, California 91325
1179
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Oklahoma City, Oklahoma 73112
158
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Orange, California 92868
1153
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Ozark, Alabama 36360
816
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Palm Harbor, Florida 34684
1097
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Panama City, Florida 32401
870
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Pembroke Pines, Florida 33026
1309
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Peoria, Illinois 61615
485
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Peoria, IL
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332
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Plano, TX
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Poway, California 92064
1129
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Powder Springs, Georgia 30127
782
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Prince Frederick, Maryland 20678
1152
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Raleigh, North Carolina 27610
1068
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Richmond, Virginia 23219
1111
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Roseville, California 95661
1269
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Roswell, Georgia 30076
795
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Sacramento, California 95821
1283
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Saint George, Utah 84790
864
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Saint Louis, Missouri 63110
418
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Saint Petersburg, Florida 33713
1115
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San Antonio, Texas 78224
576
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San Diego, California 92111
1142
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Sandy Springs, Georgia 30328
797
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Santa Barbara, California 93105
1239
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Suwanee, Georgia 30024
809
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Suwanee, GA
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Syracuse, New York 13210
1193
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Tacoma, Washington 98405
1407
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Tallahassee, Florida 32308
924
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Temecula, California 92591
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Topeka, Kansas 66606
146
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Tucker, Georgia 30084
807
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Tucson, Arizona 85704
832
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Tuscaloosa, Alabama 35406
656
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Tustin, California 92780
1152
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Vero Beach, Florida 32960
1227
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Vestavia Hills, Alabama 35209
686
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Walnut Creek, California 94598
1318
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Waltham, Massachusetts 02453
1434
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Warrenton, Virginia 20186
1086
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West Palm Beach, Florida 33409
1284
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