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
Greensboro, North Carolina 27408
2151
mi
from 91732
Greensboro, NC
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?
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Algiers,
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Austin, Texas 78731
1212
mi
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Austin, TX
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Buckley, Michigan 49620
1857
mi
from 91732
Buckley, MI
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Chicago, Illinois 60612
1728
mi
from 91732
Chicago, IL
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Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
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Greenbrae, California 94904
367
mi
from 91732
Greenbrae, CA
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Hillsborough, New Jersey 08844
2401
mi
from 91732
Hillsborough, NJ
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Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Indianapolis, Indiana 46260
1792
mi
from 91732
Indianapolis, IN
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Kettering, Ohio 45429
1898
mi
from 91732
Kettering, OH
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Kingsport, Tennessee 37660
1994
mi
from 91732
Kingsport, TN
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Kissimmee, Florida 34744
2188
mi
from 91732
Kissimmee, FL
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Lawrenceville, New Jersey 08648
2396
mi
from 91732
Lawrenceville, NJ
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Martinsburg, West Virginia 25401
2228
mi
from 91732
Martinsburg, WV
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Mission Hills, California 91345
28
mi
from 91732
Mission Hills, CA
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Pittsburgh, Pennsylvania 15224
2119
mi
from 91732
Pittsburgh, PA
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Rockville, Maryland 20852
2275
mi
from 91732
Rockville, MD
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Round Rock, Texas 78681
1208
mi
from 91732
Round Rock, TX
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San Antonio, Texas 78224
1188
mi
from 91732
San Antonio, TX
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San Diego, California 92111
106
mi
from 91732
San Diego, CA
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Slidell, Louisiana 70461
1666
mi
from 91732
Slidell, LA
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Tacoma, Washington 98405
939
mi
from 91732
Tacoma, WA
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Toms River, New Jersey 08755
2426
mi
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Toms River, NJ
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Wadsworth, Ohio 44281
2029
mi
from 91732
Wadsworth, OH
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Whiteville, North Carolina 28472
2231
mi
from 91732
Whiteville, NC
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