Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 31, 2012
End Date:August 22, 2013

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A Trial Comparing the Efficacy and Safety of Two Different Titration Algorithms for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®: SIMPLE vs. STEPWISE)

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

The aim of the trial is to compare the efficacy and safety of two different titration
algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes
mellitus previously treated with insulin glargine.


Inclusion Criteria:

- Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2
(randomisation)

- Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs
(OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase
inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks
prior to Visit 2 (randomisation) and doses should have been stable in this period of
time

- Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory
analysis

- Body mass index (BMI) below or equal to 40 kg/m^2

Exclusion Criteria:

- Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones
(TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)

- Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial
infarction; unstable angina pectoris; or coronary arterial bypass graft or
angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)

- Uncontrolled or untreated severe hypertension defined as systolic blood pressure above
or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg

- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12
months) or hypoglycaemic unawareness as judged by the investigator

- Life-threatening disease (e.g. cancer)
We found this trial at
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Anaheim, California 92801
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Albany, New York 12208
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Avon, Illinois 46123
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Bradenton, Florida 34201
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Buckley, Michigan 49620
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Charleston, South Carolina 29407
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Crystal Lake, Illinois 60012
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Dallas, Texas 75231
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Goodyear, Arizona 85395
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Greenbrae, California 94904
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Indianapolis, Indiana 46260
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Kenosha, Wisconsin 53142
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Kissimmee, Florida 34744
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Lawrenceville, New Jersey 08648
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Myrtle Beach, South Carolina 29572
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Nashua, New Hampshire 03063
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Olympia, Washington 98502
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Plantation, Florida 33324
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Spring Valley, California 91978
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Suwanee, Georgia 30024
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Tacoma, Washington 98405
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Toms River, New Jersey 08755
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Waltham, Massachusetts 02453
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