Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/3/2019
Start Date:August 31, 2013
End Date:June 30, 2015

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This trial is conducted in Europe and the United States of America (USA). The aim of the
trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared
to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes.
This trial consists of two periods: a 26 week treatment period followed by a 26 week
additional treatment period.


Inclusion Criteria: - Type 1 diabetes (diagnosed clinically) for 12 months or longer at the
time of screening (Visit 1) - Currently treated with a basal-bolus insulin regimen for at
least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin
analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior
to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by
central laboratory - Body Mass Index (BMI) below or equal to 35.0 kg/m^2 Exclusion
Criteria: - Use of any anti-diabetic drug other than insulin within the last 3 months prior
to screening (Visit 1) - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic
event during the last 12 months) or hypoglycaemic unawareness as judged by the
Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months
prior to screening (Visit 1) - Cardiovascular disease, within the last 6 months prior to
screening (Visit 1), defined as stroke, decompensated heart failure New York Heart
Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris,
coronary arterial bypass graft or angioplasty
We found this trial at
91
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Miami, Florida 33136
992
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Albany, New York 12208
513
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Albuquerque, New Mexico 87102
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Amarillo, Texas 79106
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Anaheim, California 92801
1962
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Atlanta, Georgia 30318
436
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Austin, Texas 78731
1065
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Baltimore, Maryland 21229
340
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Beaumont, Texas 77701
925
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Boca Raton, Florida 33433
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Butte, Montana 59701
1538
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Chapel Hill, North Carolina 27599
353
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Chattanooga, Tennessee 37404
362
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Chicago, Illinois 60612
274
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Columbus, Ohio 43205
1
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Concord, California 94520
2081
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Coral Gables, Florida 33134
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Crystal Lake, Illinois 60012
388
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Dallas, Texas 75231
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Denver, Colorado 80220
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Dunwoody, Georgia 30338
422
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Eagan, Minnesota 55123
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Escondido, California 92025
1936
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Fleming Island, Florida 32003
686
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Fort Lauderdale, Florida 33316
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Fresno, California 93702
1988
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Fullerton, California 92835
1960
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Greenville, North Carolina 27834
430
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Greenville, South Carolina 29607
354
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Henderson, Nevada 89052
1755
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Hoboken, New Jersey 07030
476
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Honolulu, Hawaii 96814
4501
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Houston, Texas 77030
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Hyattsville, Maryland 20782
331
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Idaho Falls, Idaho 83404
1506
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Inglewood, California 90301
1980
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Jacksonville, Florida 32207
672
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800 Scudders Mill Road
Jenkintown, Pennsylvania 19046
445
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Jersey City, New Jersey 07306
473
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Kalamazoo, Michigan 49009
211
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Kansas City, Missouri 64106
617
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La Jolla, California 92037
1954
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La Mesa, California 91942
1942
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Las Vegas, Nevada 89128
1762
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Lawrenceville, Georgia 30046
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Lawrenceville, New Jersey 08648
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Lenexa, Kansas 66219
630
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Lexington, Kentucky 40503
157
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Long Beach, California 90807
1974
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Lubbock, Texas 79423
1128
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1525
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Magna, UT
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146
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Mentor, OH
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Minneapolis, Minnesota 55404
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Mobile, Alabama 36608
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Morehead City, North Carolina 28557
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Muncie, Indiana 47304
125
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1734
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Nampa, ID
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Nashua, New Hampshire 03063
629
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New York, New York 10029
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Newark, Delaware 19713
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North Hollywood, California 91606
1976
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Northridge, California 91325
1981
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Olympia, Washington 98502
2033
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Omaha, Nebraska 68114
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Philadelphia, Pennsylvania 19104
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Portland, Maine 04101
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Portland, Oregon 97239
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Poway, California 92064
1938
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Renton, Washington 98057
2001
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Rochester, New York 14609
355
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Rockville, Maryland 20852
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Roswell, Georgia 30076
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Round Rock, Texas 78681
1052
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San Diego, California 92111
1951
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Sanford, Florida 32771
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Santa Barbara, California 93105
2039
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Smithtown, New York 11787
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Spokane, Washington 99202
1776
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Springfield, Illinois 62702
349
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Springfield, Missouri 65807
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Staten Island, New York 10301
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Tucson, Arizona 85704
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Ventura, California 93003
2017
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Walnut Creek, California 94598
2084
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Waltham, Massachusetts 02453
633
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Worcester, Massachusetts 01655
604
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