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
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Austin, Texas 78731
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Buckley, Michigan 49620
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Chicago, Illinois 60612
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Chicago, IL
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Dallas, Texas 75231
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Greenbrae, California 94904
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Greenbrae, CA
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Greensboro, North Carolina 27408
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Greensboro, NC
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Hillsborough, New Jersey 08844
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Hillsborough, NJ
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Houston, Texas 77030
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Houston, TX
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Kettering, Ohio 45429
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Kettering, OH
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Kingsport, Tennessee 37660
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Kingsport, TN
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Kissimmee, Florida 34744
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Kissimmee, FL
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Lawrenceville, New Jersey 08648
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Lawrenceville, NJ
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Martinsburg, West Virginia 25401
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Martinsburg, WV
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Mission Hills, California 91345
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Mission Hills, CA
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Pittsburgh, Pennsylvania 15224
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Rockville, Maryland 20852
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Round Rock, Texas 78681
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Round Rock, TX
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San Antonio, Texas 78224
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San Antonio, TX
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San Diego, California 92111
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San Diego, CA
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Slidell, Louisiana 70461
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Slidell, LA
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Tacoma, Washington 98405
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Tacoma, WA
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Toms River, New Jersey 08755
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Toms River, NJ
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Wadsworth, Ohio 44281
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Whiteville, North Carolina 28472
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Whiteville, NC
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