Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

• Change in 8-point Plasma Glucose Profile [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]
  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
• Percentage of Subjects Achieving HbA1c Less Than 7.0% [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment
• Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  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
• Hypoglycaemic Episodes [ Time Frame: weeks 0-16 ] [ Designated as safety issue: Yes ]
  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.
• Hypoglycaemic Episodes, Diurnal/Nocturnal [ Time Frame: weeks 0-16 ] [ Designated as safety issue: Yes ]
  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).

• 8-point plasma glucose profile [ Time Frame: At 16 weeks ] [ Designated as safety issue: No ]
• Percentage of subjects achieving HbA1c less than 7.0% [ Time Frame: At 16 weeks ] [ Designated as safety issue: No ]
• Percentage of subjects achieving HbA1c equal or below 6.5% [ Time Frame: At 16 weeks ] [ Designated as safety issue: No ]
• Safety profile [ Time Frame: During treatment ] [ Designated as safety issue: Yes ]

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.

• Diabetes
• Diabetes Mellitus, Type 2

• Drug: biphasic insulin aspart 30
  Subcutaneous (under the skin) injection, twice daily
  Other Name: NovoMix® 30
• Drug: metformin
  Tablets, 1000 - 2000 mg daily

Inclusion Criteria:

• Type 2 diabetes
• Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months
• HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)
• BMI (Body Mass Index) maximum 40 kg/m2

Exclusion Criteria:

• Metformin contraindications according to local practice
• Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial