Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 Diabetes

A 24-week, Randomised, Multi-centre, Double-blind, Parallel-group Trial to Investigate the Safety and the Efficacy of NN2000-Mix30 Compared to NN-X14Mix30 NovoRapid®30Mix) in Subjects With Type 2 Diabetes Mellitus on a Twice Daily Regimen

This trial is conducted in Japan. The aim of this trial was to investigate the safety and efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced by current process in Japanese subjects with type 2 diabetes.

Inclusion Criteria:

• Subjects with type 2 diabetes
• Subjects with insulin treatment for at least 24 weeks
• Current treatment with premixed biphasic human insulin preparation for at least 12 weeks
• HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

• Recurrent severe hypoglycaemia
• Proliferative retinopathy or maculopathy requiring acute treatment
• Impaired renal function
• Cardiac diseases
• Uncontrolled hypertension
• Subjects with known malignant tumour
• Total daily insulin dose greater than or equal to 100 IU