Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes

Comparison of the Efficacy on Glycaemic Control and Safety Profile of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 Both in Combination With Metformin in Insulin-naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Drugs (OADs) Therapy

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.

Inclusion Criteria:

• Type 2 diabetes diagnosed for at least 6 months
• Insulin-naive (less than or equal to 1 week of daily use of insulin therapy)
• Treatment with metformin as monotherapy or in combination therapy with other OAD(s) for at least 3 months prior to this trial
• Currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks
• Currently at least one of other OAD(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks
• Glycosylated haemoglobin (HbA1c) between 7.5-11.0%
• Body Mass Index (BMI) between 18.5 - 35.0 kg/m^2
• Be able and willing to perform continuous glucose monitoring system (CGMS ) and self-monitored blood glucose (SMBG)

Exclusion Criteria:

• Known or suspected allergy to trial product(s) or related products
• Any contraindication of metformin
• Receipt of investigational drug within the last 3 months prior to this trial
• Any history of chronic insulin therapy (more than 1 week of daily use)
• Systemically treated with thiazolidinediones (TZDs) for more than one month within 6 months prior to this trial
• Pregnancy, nursing mother, or unwillingness to use adequate contraception