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
New Windsor, New York 12553
1288
mi
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New Windsor, NY
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Anaheim, California 92801
1157
mi
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Anaheim, CA
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Atlanta, Georgia 30318
801
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Atlanta, GA
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Aurora, Colorado 80010
403
mi
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Aurora, CO
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Avon, Illinois 46123
443
mi
from
Avon, IL
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Boynton Beach, Florida 33472
1292
mi
from
Boynton Beach, FL
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Bradenton, Florida 34201
1142
mi
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Bradenton, FL
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Buckley, Michigan 49620
784
mi
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Buckley, MI
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Butte, Montana 59701
944
mi
from
Butte, MT
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Carlisle, Ohio 45005
896
mi
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Carlisle, OH
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Chattanooga, Tennessee 37404
721
mi
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Chattanooga, TN
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Chesterfield, Missouri 63017
398
mi
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Chesterfield, MO
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Cleveland, Ohio 44106
894
mi
from
Cleveland, OH
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Colorado Springs, Colorado 80910
383
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Colorado Springs, CO
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Cooper City, Florida 33024
1304
mi
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Cooper City, FL
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Dallas, Texas 75231
341
mi
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Dallas, TX
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744
mi
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Dayton, OH
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Decatur, Georgia 30033
805
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Decatur, GA
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Detroit, Michigan 48201
841
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Detroit, MI
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East Providence, Rhode Island 02914
1426
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East Providence, RI
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?
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Edmonton,
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Elkhorn, Nebraska 68022
258
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Elkhorn, NE
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Fort Lauderdale, Florida 33316
1309
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Fort Lauderdale, FL
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Franklin, Ohio 45005
739
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Franklin, OH
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Fresno, California 93702
1205
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Fresno, CA
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Gaffney, South Carolina 29341
916
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Gaffney, SC
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Glendale, Arizona 85306
853
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Glendale, AZ
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Greenbrae, California 94904
1343
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Greenbrae, CA
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Hickory, North Carolina 28602
921
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Hickory, NC
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339
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Hurst, TX
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Indianapolis, Indiana 46260
643
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Indianapolis, IN
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Jacksonville, Florida 32207
1058
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Jacksonville, FL
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Jefferson City, Missouri 65109
312
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Jefferson City, MO
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Kenosha, Wisconsin 53142
622
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Kenosha, WI
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Kingsport, Tennessee 37660
843
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Kingsport, TN
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Lomita, California 90717
1178
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Lomita, CA
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Louisville, Kentucky 40213
659
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Louisville, KY
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Madisonville, Kentucky 42431
566
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Madisonville, KY
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737
mi
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Mason, OH
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Mesa, Arizona 85206
840
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Mesa, AZ
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Miami, Florida 33136
1320
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Miami, FL
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Midlothian, Virginia 23114
1101
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Midlothian, VA
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Milwaukee, Wisconsin 53209
636
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Milwaukee, WI
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Mineola, New York 11501
1305
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Mineola, NY
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Monroe, Louisiana 71203
484
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Monroe, LA
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Muncie, Indiana 47304
688
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Muncie, IN
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778
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Murray, UT
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North Massapequa, New York 11758
1315
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North Massapequa, NY
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Northport, New York 11768
1321
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Northport, NY
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Northridge, California 91325
1179
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Northridge, CA
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Omaha, Nebraska 68114
261
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Omaha, NE
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Paducah, Kentucky 42003
507
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Paducah, KY
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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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Phoenix, Arizona 85053
852
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Phoenix, AZ
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332
mi
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Plano, TX
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Plantation, Florida 33324
1302
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Port Orchard, Washington 98366
1422
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Port Orchard, WA
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Roswell, Georgia 30076
795
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Roswell, GA
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Saint Louis, Missouri 63110
418
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Saint Louis, MO
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San Diego, California 92111
1142
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San Diego, CA
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San Ramon, California 94583
1315
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Spring Hill, Tennessee 37174
765
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Tampa, Florida 33612
1112
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Tempe, Arizona 85283
847
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Tempe, AZ
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Toms River, New Jersey 08755
1276
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Topeka, Kansas 66606
146
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Topeka, KS
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Troy, Michigan 48098
742
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Troy, MI
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Tullahoma, Tennessee 37388
664
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Walnut Creek, California 94598
1318
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Waterbury, Connecticut 06708
1337
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Wilmington, North Carolina 28401
1135
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Wilmington, NC
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