Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

• 9-point Self-measured Plasma Glucose Profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. 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.
• Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin.
• Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat) [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale.
• Number of Hypoglycaemic Episodes [ Time Frame: weeks 0-26 ] [ Designated as safety issue: Yes ]
  Total number of hypoglycaemic episodes experienced in each treatment arm. 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.
• Number of Subjects Reporting Treatment Emergent Adverse Events [ Time Frame: weeks 0-26 ] [ Designated as safety issue: Yes ]
  Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration.

• 9-point plasma glucose profiles
• Percentage of subjects reaching certain levels of HbA1c
• Number of hypoglycaemic episodes
• Treatment Satisfaction
• Adverse events (AEs)

This trial is conducted in Africa, Asia, Europe, Oceania and South America.

This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

• Diabetes
• Diabetes Mellitus, Type 2

• Drug: biphasic insulin aspart
  Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
• Drug: insulin glargine
  Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
• Drug: metformin
  Tablets, 2550 mcg. Administered once daily
• Drug: glimepiride
  tablets 2 mg. 4, 6 or 8 mg administered once daily

• Experimental: BIAsp 30
  biphasic insulin aspart 30 + metformin + glimepiride
  Interventions:

  • Drug: biphasic insulin aspart
  • Drug: metformin
  • Drug: glimepiride
• Active Comparator: Glargine
  insulin glargine + metformin + glimepiride
  Interventions:

  • Drug: insulin glargine
  • Drug: metformin
  • Drug: glimepiride

Inclusion Criteria:

• Type 2 diabetes
• Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
• Ongoing stable treatment with metformin for at least 2 months
• Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
• Insulin naive
• HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)

Exclusion Criteria:

• Metformin contraindication according to local practice
• TZD (thiazolidinedione) treatment for the last 5 months before trial start
• Systemic treatment with any corticosteroid 3 months before trial start
• Any disease or condition which according to the Investigator would interfere with the trial