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
Troy, Michigan 48098
1757
mi
from 98109
Troy, MI
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Anaheim, California 92801
979
mi
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Anaheim, CA
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Atlanta, Georgia 30318
2179
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Atlanta, GA
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Aurora, Colorado 80010
1026
mi
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Aurora, CO
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Avon, Illinois 46123
1640
mi
from 98109
Avon, IL
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Boynton Beach, Florida 33472
2701
mi
from 98109
Boynton Beach, FL
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Bradenton, Florida 34201
2552
mi
from 98109
Bradenton, FL
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Buckley, Michigan 49620
1754
mi
from 98109
Buckley, MI
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Butte, Montana 59701
476
mi
from 98109
Butte, MT
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Carlisle, Ohio 45005
2092
mi
from 98109
Carlisle, OH
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Chattanooga, Tennessee 37404
2085
mi
from 98109
Chattanooga, TN
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Chesterfield, Missouri 63017
1702
mi
from 98109
Chesterfield, MO
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Cleveland, Ohio 44106
2020
mi
from 98109
Cleveland, OH
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Colorado Springs, Colorado 80910
1070
mi
from 98109
Colorado Springs, CO
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Cooper City, Florida 33024
2714
mi
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Cooper City, FL
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Dallas, Texas 75231
1677
mi
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Dallas, TX
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1956
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Dayton, OH
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Decatur, Georgia 30033
2182
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Decatur, GA
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Detroit, Michigan 48201
1933
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Detroit, MI
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East Providence, Rhode Island 02914
2488
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East Providence, RI
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?
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Edmonton,
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Elkhorn, Nebraska 68022
1352
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Elkhorn, NE
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Fort Lauderdale, Florida 33316
2719
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Fort Lauderdale, FL
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Franklin, Ohio 45005
1961
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Franklin, OH
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Fresno, California 93702
763
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Fresno, CA
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Gaffney, South Carolina 29341
2250
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Gaffney, SC
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Glendale, Arizona 85306
1103
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Glendale, AZ
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Greenbrae, California 94904
669
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Greenbrae, CA
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Hickory, North Carolina 28602
2238
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Hickory, NC
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1661
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Hurst, TX
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Indianapolis, Indiana 46260
1868
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Indianapolis, IN
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Jacksonville, Florida 32207
2454
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Jacksonville, FL
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Jefferson City, Missouri 65109
1632
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Jefferson City, MO
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Kenosha, Wisconsin 53142
1702
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Kenosha, WI
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Kingsport, Tennessee 37660
2150
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Kingsport, TN
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Lomita, California 90717
978
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Lomita, CA
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Louisville, Kentucky 40213
1944
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Louisville, KY
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Madisonville, Kentucky 42431
1893
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Madisonville, KY
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1967
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Mason, OH
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Mesa, Arizona 85206
1124
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Mesa, AZ
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Miami, Florida 33136
2730
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Miami, FL
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Midlothian, Virginia 23114
2343
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Midlothian, VA
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Milwaukee, Wisconsin 53209
1687
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Milwaukee, WI
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Mineola, New York 11501
2417
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Mineola, NY
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Monroe, Louisiana 71203
1890
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Monroe, LA
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Muncie, Indiana 47304
1890
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Muncie, IN
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706
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Murray, UT
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New Windsor, New York 12553
2376
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New Windsor, NY
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North Massapequa, New York 11758
2427
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Northport, New York 11768
2426
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Northport, NY
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Northridge, California 91325
946
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Northridge, CA
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Omaha, Nebraska 68114
1367
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Omaha, NE
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Paducah, Kentucky 42003
1852
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Paducah, KY
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Pembroke Pines, Florida 33026
2719
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Pembroke Pines, FL
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Peoria, Illinois 61615
1678
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Peoria, IL
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Phoenix, Arizona 85053
1116
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Phoenix, AZ
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1671
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Plano, TX
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Plantation, Florida 33324
2712
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Plantation, FL
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Port Orchard, Washington 98366
11
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Port Orchard, WA
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Roswell, Georgia 30076
2168
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Roswell, GA
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Saint Louis, Missouri 63110
1721
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Saint Louis, MO
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San Diego, California 92111
1065
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San Ramon, California 94583
681
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San Ramon, CA
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Spring Hill, Tennessee 37174
2099
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Spring Hill, TN
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Tampa, Florida 33612
2522
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Tampa, FL
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Tempe, Arizona 85283
1124
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Tempe, AZ
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Toms River, New Jersey 08755
2418
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Topeka, Kansas 66606
1455
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Tullahoma, Tennessee 37388
2029
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Tullahoma, TN
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Walnut Creek, California 94598
664
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Walnut Creek, CA
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Waterbury, Connecticut 06708
2418
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Waterbury, CT
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Wilmington, North Carolina 28401
2455
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Wilmington, NC
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