Efficacy and Safety of Insulin Aspart Versus Glibenclamide in Type 2 Diabetes

A Clinical Trial to Study the Efficacy and Safety of Insulin Aspart Three Times Per Day Compared to Glibenclamide Once or Twice Daily in Type 2 Diabetes by Comparison of Ability to Control Blood Glucose

This trial is conducted in Japan. This is a clinical trial to study the efficacy and safety of thrice daily Insulin Aspart compared to Glibenclamide in type 2 diabetic patients.

Inclusion Criteria:

• Type 2 diabetes
• Diet therapy for at least 12 weeks, or diet therapy and oral hypoglycaemic agent(s) other than SU agents for at least 12 weeks
• No previous treatment with insulin and/or SU agents
• HbA1c between 7.5% and 10.0%
• Body Mass Index (BMI) below 30.0 kg/m2

Exclusion Criteria:

• Proliferative retinopathy or maculopathy requiring acute treatment
• Impaired hepatic function
• Impaired renal function
• Cardiac diseases
• Uncontrolled hypertension
• Known hypoglycaemia unawareness or recurrent major hypoglycaemia
• Current treatment with systemic corticosteroids