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 |
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).
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
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