A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2013
End Date:March 2014

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A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily (BOOST®: INTENSIFY BID)

This trial is conducted globally. The aim of the trial is to compare efficacy of insulin
degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD)
versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in
controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an
extension to trial NN5401-3941 (NCT01680341).


Inclusion Criteria:

- HbA1c equal to or above 7.0% measured after 26 weeks of treatment in NN5401-3941
(NCT01680341), by central laboratory

Exclusion Criteria:

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

- Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate
aminotransferase (ASAT) equal to or above 2.5 times upper limit of normal

- Impaired renal function defined as serum-creatinine equal to or above 125 micromol/L
(equal to or above 1.4 mg/dL) for males and equal to or above 110 micromol/L (equal
to or above 1.3 mg/dL) for females
We found this trial at
17
sites
Bradenton, Florida 34208
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Bradenton, FL
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Anaheim, California 92801
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Anaheim, CA
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Buckley, Michigan 49620
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Buckley, MI
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Crystal Lake, Illinois 60012
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Crystal Lake, IL
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Fort Worth, Texas 76104
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Fort Worth, TX
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Greenbrae, California 94904
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Greenbrae, CA
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Kissimmee, Florida 34741
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Kissimmee, FL
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Lawrenceville, New Jersey 08648
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Lawrenceville, NJ
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Plantation, Florida 33324
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Plantation, FL
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San Diego, California 92101
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San Diego, CA
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Slidell, Louisiana 70461
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Slidell, LA
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Spring Valley, California 91978
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Spring Valley, CA
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St. Ingbert,
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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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Waltham, Massachusetts 02453
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Waltham, MA
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