Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia

This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.

Inclusion Criteria:

• After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

• Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
• Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir
• Subjects who were previously enrolled in this study
• Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months