This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
293
Subcutaneous (under the skin) injection, twice daily
Tablets, 1000 - 2000 mg daily
Unnamed facility
Beijing, Beijing Municipality, China
Change in HbA1c (Glycosylated Haemoglobin A1c)
Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)
Time frame: week 0, week 16
Change in 8-point Plasma Glucose Profile
Summary of change in 8-point plasma glucose profile by week and time. The 8 time points measured were: Before each meal (breakfast, lunch and dinner), at 2 hours after each meal (breakfast, lunch and dinner), at bedtime, and at 3 AM, measured over 16 weeks of treatment
Time frame: week 0, week 16
Percentage of Subjects Achieving HbA1c Less Than 7.0%
Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment
Time frame: week 16
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below or equal to 6.5% after 16 weeks of treatment
Time frame: week 16
Hypoglycaemic Episodes
Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment). 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
Hypoglycaemic Episodes, Diurnal/Nocturnal
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment) during the day (diurnal) and the night (nocturnal).
Time frame: weeks 0-16