Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes

An Open-labelled, Randomised, Parallel Group, Multicentre, Safety and Efficacy Study of NN-X14Mix50 (BIAsp50) in a Twice Daily Regimen in Type 2 Diabetic Subjects

This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human insulin (BHI) 50 in subjects with type 2 diabetes.

Inclusion Criteria:

• Subjects with type 2 diabetes
• Subjects with insulin treated for at least 24 weeks
• HbA1c maximum 11.0%
• Body mass index (BMI) below 30.0 kg/m^2
• Patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (SMBG) and are able to take measures against hypoglycaemic episodes

Exclusion Criteria:

• Recurrent severe hypoglycaemia
• Subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year
• Impaired hepatic function
• Impaired renal function
• Cardiac diseases
• Uncontrolled hypertension
• Subjects with history of severe allergic or severe hypersensitive reactions
• Total daily insulin dose at least 100 IU
• Treatment with oral hypoglycaemic agentsvwithin the last 4 weeks