Primary Objective: To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen. Secondary Objective: To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event is taken into account.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
161
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: twice daily
Administrative Office
Seoul, South Korea
Change in hemoglobin A1c level (HbA1c)
Time frame: At 6 months of treatment
Rate of hypoglycemic events (total, severe, nocturnal)
Time frame: from baseline to the study endpoint (over 6 months of treatment)
Proportion of patients with HbA1c < 7%
Time frame: from baseline to the study endpoint (over 6 months of treatment)
Change in body weight
Time frame: from baseline to the study endpoint (over 6 months of treatment)
Reactive Oxidative Stress (ROS) level changes
Time frame: from baseline to the study endpoint (over 6 months of treatment)
Change in Quality of Life
Time frame: from baseline to the study endpoint (over 6 months of treatment)
Continuous Glucose Monitoring System (CGMS) data
Time frame: at baseline, 3 and 6 months
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