Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:September 9, 2013
End Date:January 22, 2015

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This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare
FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin
glargine and metformin in adults with type 2 diabetes.


Inclusion Criteria: - Type 2 diabetes (diagnosed clinically) for 6 months or longer at time
of screening (visit 1) - Treated with basal insulin for at least 6 months prior to
screening (visit 1) - Current once daily treatment with insulin NPH (Neutral Protamine
Hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit
(visit 1) - Current treatment with: a. metformin with unchanged dosing for at least 3
months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b.
metformin in combination with sulfonylurea (SU) or glinide or DPP-IV (dipeptidyl
peptidase-4) inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for
at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
- HbA1c by central laboratory: a. 7.0 - 9.5% (53 - 80 mmol/mol) (both inclusive) in the
metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 - 75 mmol/mol) (both
inclusive) in the metformin + other OAD (oral antidiabetic drug) (SU, glinide, DDP-IV
inhibitors, AGI) combination group at the screening visit (visit 1) - Body mass index (BMI)
equal to or below 40.0 kg/m^2 Exclusion Criteria: - Any use of bolus insulin, except
short-term use due to intermittent illness (no longer than 14 days consecutive treatment)
and not 3 months prior to the screening visit (visit 1) - Use of GLP-1 (glucagon-like
peptide-1) agonists and/or TZDs within the last 3 months prior to screening (visit 1) -
Recurrent severe hypoglycaemia (more than 1 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 or coronary arterial bypass graft or
angioplasty
We found this trial at
72
sites
Greenbrae, California 94904
2109
mi
from 43215
Greenbrae, CA
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Anaheim, California 92801
1962
mi
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Anaheim, CA
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Atlanta, Georgia 30318
436
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Atlanta, GA
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Aurora, Colorado 80010
1155
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Aurora, CO
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Avon, Illinois 46123
393
mi
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Avon, IL
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Boynton Beach, Florida 33472
943
mi
from 43215
Boynton Beach, FL
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Bradenton, Florida 34201
868
mi
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Bradenton, FL
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Buckley, Michigan 49620
341
mi
from 43215
Buckley, MI
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Butte, Montana 59701
1538
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Butte, MT
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Carlisle, Ohio 45005
89
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Carlisle, OH
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Chattanooga, Tennessee 37404
362
mi
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Chattanooga, TN
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Chesterfield, Missouri 63017
413
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Chesterfield, MO
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Cleveland, Ohio 44106
126
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Cleveland, OH
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Colorado Springs, Colorado 80910
1161
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Colorado Springs, CO
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Cooper City, Florida 33024
973
mi
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Cooper City, FL
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Dallas, Texas 75231
905
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Dallas, TX
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65
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Dayton, OH
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Decatur, Georgia 30033
433
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Decatur, GA
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Detroit, Michigan 48201
163
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Detroit, MI
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East Providence, Rhode Island 02914
621
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East Providence, RI
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?
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Edmonton,
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Elkhorn, Nebraska 68022
698
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Elkhorn, NE
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Fort Lauderdale, Florida 33316
972
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Fort Lauderdale, FL
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Franklin, Ohio 45005
73
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Franklin, OH
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Fresno, California 93702
1988
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Fresno, CA
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Gaffney, South Carolina 29341
346
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Gaffney, SC
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Glendale, Arizona 85306
1662
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Glendale, AZ
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Hickory, North Carolina 28602
306
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Hickory, NC
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925
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Hurst, TX
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Indianapolis, Indiana 46260
166
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Indianapolis, IN
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Jacksonville, Florida 32207
672
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Jacksonville, FL
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Jefferson City, Missouri 65109
498
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Jefferson City, MO
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Kenosha, Wisconsin 53142
308
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Kenosha, WI
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Kingsport, Tennessee 37660
237
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Kingsport, TN
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Lomita, California 90717
1982
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Lomita, CA
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Louisville, Kentucky 40213
189
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Louisville, KY
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Madisonville, Kentucky 42431
302
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Madisonville, KY
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80
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Mason, OH
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Mesa, Arizona 85206
1650
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Mesa, AZ
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Miami, Florida 33136
992
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Miami, FL
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Midlothian, Virginia 23114
335
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Midlothian, VA
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Milwaukee, Wisconsin 53209
329
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Milwaukee, WI
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Mineola, New York 11501
496
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Mineola, NY
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Monroe, Louisiana 71203
721
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Monroe, LA
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Muncie, Indiana 47304
125
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Muncie, IN
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1514
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Murray, UT
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New Windsor, New York 12553
482
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New Windsor, NY
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North Massapequa, New York 11758
505
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Northport, New York 11768
512
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Northport, NY
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Northridge, California 91325
1981
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Northridge, CA
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Omaha, Nebraska 68114
682
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Omaha, NE
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Paducah, Kentucky 42003
361
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Paducah, KY
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Pembroke Pines, Florida 33026
978
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Pembroke Pines, FL
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Peoria, Illinois 61615
349
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Peoria, IL
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Phoenix, Arizona 85053
1662
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Phoenix, AZ
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898
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Plano, TX
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Plantation, Florida 33324
970
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Plantation, FL
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Port Orchard, Washington 98366
2018
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Port Orchard, WA
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Roswell, Georgia 30076
414
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Saint Louis, Missouri 63110
394
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San Diego, California 92111
1951
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San Ramon, California 94583
2084
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Spring Hill, Tennessee 37174
279
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Tampa, Florida 33612
823
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Tempe, Arizona 85283
1657
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Toms River, New Jersey 08755
467
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Topeka, Kansas 66606
676
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Troy, Michigan 48098
303
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Tullahoma, Tennessee 37388
362
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Walnut Creek, California 94598
2084
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Waterbury, Connecticut 06708
531
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Waterbury, CT
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Wilmington, North Carolina 28401
485
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Wilmington, NC
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