A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:February 21, 2013
End Date:January 9, 2014

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This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare the difference in change in glycosylated haemoglobin
(HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs
(OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.


Inclusion Criteria:

- Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at
least 26 weeks prior to screening (visit 1)

- Treatment with basal insulin for at least 12 weeks prior to randomisation with or
without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors,
alfa-glucosidase-inhibitors

- HbA1c 7.0% - 10.0%

- Body mass index (BMI) less than or equal to 40.0 kg/m^2

Exclusion Criteria:

- Treatment with glucose-lowering agent(s) other than those stated in the inclusion
criteria

- Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial
infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty

- Chronic disorder or disease which might jeopardise safety or compliance

- Malignant neoplasms

- Recurrent severe hypoglycaemia
We found this trial at
26
sites
Lawrenceville, New Jersey 08648
1248
mi
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Lawrenceville, NJ
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?
mi
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Algiers,
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Austin, Texas 78731
517
mi
from
Austin, TX
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Buckley, Michigan 49620
784
mi
from
Buckley, MI
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Chicago, Illinois 60612
609
mi
from
Chicago, IL
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Dallas, Texas 75231
341
mi
from
Dallas, TX
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Greenbrae, California 94904
1343
mi
from
Greenbrae, CA
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Greensboro, North Carolina 27408
1001
mi
from
Greensboro, NC
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Hillsborough, New Jersey 08844
1253
mi
from
Hillsborough, NJ
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Houston, Texas 77030
572
mi
from
Houston, TX
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Indianapolis, Indiana 46260
643
mi
from
Indianapolis, IN
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Kettering, Ohio 45429
747
mi
from
Kettering, OH
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Kingsport, Tennessee 37660
843
mi
from
Kingsport, TN
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Kissimmee, Florida 34744
1150
mi
from
Kissimmee, FL
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Martinsburg, West Virginia 25401
1076
mi
from
Martinsburg, WV
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Mission Hills, California 91345
1176
mi
from
Mission Hills, CA
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Pittsburgh, Pennsylvania 15224
971
mi
from
Pittsburgh, PA
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Rockville, Maryland 20852
1122
mi
from
Rockville, MD
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Round Rock, Texas 78681
499
mi
from
Round Rock, TX
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San Antonio, Texas 78224
576
mi
from
San Antonio, TX
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San Diego, California 92111
1142
mi
from
San Diego, CA
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Slidell, Louisiana 70461
691
mi
from
Slidell, LA
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Tacoma, Washington 98405
1407
mi
from
Tacoma, WA
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Toms River, New Jersey 08755
1276
mi
from
Toms River, NJ
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Wadsworth, Ohio 44281
887
mi
from
Wadsworth, OH
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Whiteville, North Carolina 28472
1091
mi
from
Whiteville, NC
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