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

• Number of all minor hypoglycaemic events [ Time Frame: during 4 weeks preceding each visit ] [ Designated as safety issue: Yes ]
• Number of all major hypoglycaemic events [ Time Frame: during 13 weeks preceding each visit ] [ Designated as safety issue: Yes ]
• HbA1c [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]
• Percentage of subjects to reach HbA1c below 7.0% [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
• The effect on glycaemic control as measured by FPG (fasting plasma glucose) [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
• The effect on glycamic control as measured by PG profile [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
• Change in body weight [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]

• Number of all minor hypoglycaemic events [ Time Frame: during 4 weeks preceding each visit ] [ Designated as safety issue: Yes ]
• Number of all major hypoglycaemic events [ Time Frame: during 13 weeks preceding each visit ] [ Designated as safety issue: Yes ]
• HbA1c [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]
• Percentage of subjects to reach HbA1c below 7.0% [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
• The effect on glycamic control as measured by FPG (fasting plasma glucose) [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
• The effect on glycamic control as measured by PG profile [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
• Change in body weight [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]

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.

Patients from speciality practice settings who have been deemed appropriate to receive biphasic insulin aspart 30 or insulin detemir as new treatment and as part of routine out-patient care by the prescribing physician.

• Diabetes
• Diabetes Mellitus, Type 2

• Drug: insulin detemir
  Safety and effectiveness data collection in connection with the use of the drug.
  Other Names:

  • NN304
  • Levemir®
• Drug: biphasic insulin aspart 30
  Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.

• Insulin detemir
  Intervention: Drug: insulin detemir
• Biphasic insulin aspart 30
  Intervention: Drug: biphasic insulin aspart 30

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