This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
441
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner
Tablets, 500 - 2000 mg, once, twice or three times daily
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch
Unnamed facility
Beijing, Beijing Municipality, China
Change in Glycosylated Haemoglobin A1c (HbA1c)
Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)
Time frame: week 0, week 16
The Percentage of Subjects Achieving HbA1c Treatment Targets
The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%.
Time frame: week 16
Change and Daily Average in 8-point Plasma Glucose
Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment.
Time frame: week 0, week 16
Change and Daily Average in Prandial Plasma Glucose Increment
Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment.
Time frame: week 0, week 16
The Total Increase in Total Daily Insulin Dose Per Body Weight
The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16).
Time frame: week 0, week 16
Change in Body Weight
Change in body weight from baseline (week 0) to end of treatment (week 16)
Time frame: week 0, week 16
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Number of Hypoglycaemic Episodes
Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.
Time frame: weeks 0-16
Number of Nocturnal Hypoglycaemic Episodes
Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.
Time frame: weeks 0-16