This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
245
Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms
Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms
Unnamed facility
Tehran, Iran
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11
Estimated mean change from baseline in HbA1c after 11 weeks of treatment
Time frame: Week 0, Week 11
Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36
Estimated mean change from baseline in FPG after 36 weeks of treatment
Time frame: Week 0, Week 36
Number of Treatment Emergent Hypoglycaemic Episodes
A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.
Time frame: Week 0 to Week 36
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