Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes

A 48-week, Randomised, Multi-centre, Openlabelled, Parallel-group Trial to Compare the Efficacy and the Safety of NN304 (Insulin Detemir) and NPH Human Insulin in Subjects With Insulin Requiring Diabetes Mellitus on a Basal-bolus Regimen

This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in subjects with insulin requiring diabetes.

Inclusion Criteria:

• Duration of diabetes mellitus for at least 2 years
• Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
• HbA1C below 11.0%

Exclusion Criteria:

• Impaired renal function
• Impaired hepatic function
• Serious heart diseases
• Known hypoglycaemia unawareness or recurrent major hypoglycaemia
• Proliferative retinopathy or maculopathy requiring acute treatment
• Uncontrolled treated/untreated hypertension
• Current treatment with total insulin dose of more than 100 IU/day
• Current treatment or expected at the screening to start treatment with systemic corticosteroids