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
1127
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Albany, New York 12208
316
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Albuquerque, New Mexico 87102
1513
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Amarillo, Texas 79106
1267
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Anaheim, California 92801
2127
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Atlanta, Georgia 30318
625
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Austin, Texas 78731
1281
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Baltimore, Maryland 21229
259
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Beaumont, Texas 77701
1143
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Boca Raton, Florida 33433
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Butte, Montana 59701
1628
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Chapel Hill, North Carolina 27599
431
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Chattanooga, Tennessee 37404
567
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Chicago, Illinois 60612
395
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Columbus, Ohio 43205
217
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Concord, California 94520
2219
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Coral Gables, Florida 33134
1132
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Crystal Lake, Illinois 60012
577
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Dallas, Texas 75231
1116
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Denver, Colorado 80220
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Dunwoody, Georgia 30338
611
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Eagan, Minnesota 55123
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Escondido, California 92025
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Fleming Island, Florida 32003
835
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Fort Lauderdale, Florida 33316
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Fresno, California 93702
2136
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Fullerton, California 92835
2125
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Greenville, North Carolina 27834
469
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Greenville, South Carolina 29607
518
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Henderson, Nevada 89052
1915
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Hoboken, New Jersey 07030
320
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Honolulu, Hawaii 96814
4638
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Houston, Texas 77030
1213
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Hyattsville, Maryland 20782
268
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Idaho Falls, Idaho 83404
1618
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Inglewood, California 90301
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Jacksonville, Florida 32207
821
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800 Scudders Mill Road
Jenkintown, Pennsylvania 19046
303
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Jersey City, New Jersey 07306
318
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Kalamazoo, Michigan 49009
292
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Kansas City, Missouri 64106
793
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La Jolla, California 92037
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La Mesa, California 91942
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Las Vegas, Nevada 89128
1921
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Lawrenceville, Georgia 30046
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Lawrenceville, New Jersey 08648
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Lenexa, Kansas 66219
807
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Lexington, Kentucky 40503
372
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Long Beach, California 90807
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Lubbock, Texas 79423
1327
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1658
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77
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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
311
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1842
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Nashua, New Hampshire 03063
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New York, New York 10029
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Newark, Delaware 19713
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North Hollywood, California 91606
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Northridge, California 91325
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Olympia, Washington 98502
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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
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Renton, Washington 98057
2078
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Rochester, New York 14609
139
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Rockville, Maryland 20852
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Roswell, Georgia 30076
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Round Rock, Texas 78681
1267
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San Diego, California 92111
2123
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Sanford, Florida 32771
925
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Santa Barbara, California 93105
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Smithtown, New York 11787
359
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Spokane, Washington 99202
1852
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Springfield, Illinois 62702
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Springfield, Missouri 65807
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Staten Island, New York 10301
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Ventura, California 93003
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Waltham, Massachusetts 02453
444
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Worcester, Massachusetts 01655
417
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