This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50 (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
161
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
Unnamed facility
Beijing, Beijing Municipality, China
2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test
The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value.
Time frame: After 4 weeks of treatment in each treatment sequence
-1-hour PPG Increment Following a Standard Meal Test
The 1-h PPG increment is the difference between the plasma glucose (PG) value at 60 minutes after standard meal test and the fasting PG value.
Time frame: After 4 weeks of treatment in each treatment sequence
-IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test
AUC for plasma glucose was calculated by the trapezoidal method using 30-min sampling time points, and IAUC for PPG (0-2h) data was analyzed using a normal linear mixed model.
Time frame: After 4 weeks of treatment in each treatment sequence
2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile
PPG increments over each of the 3 main meals were derived from the 8-point SMPG profile as the difference between PG values available 120 minutes after meal and before meal.
Time frame: After 4 weeks of treatment in each treatment sequence
The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile
Mean post prandial PG increment over all meals was derived as the mean of all available meal increments.
Time frame: After 4 weeks of treatment in each treatment sequence
Incidence of Hypoglycemic Episodes
Treatment Emergent Hypoglycemic Episode refers to those the onset of the episode is on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. Results are presented by American Diabetes Association classification of hypoglycemia.
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Time frame: During 4 weeks of treatment in each treatment sequence
Incidence of AEs (Adverse Event)
Treatment emergent AE (TEAE) is defined as an event that has onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment.
Time frame: During 4 weeks of treatment in each treatment sequence