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.
Study Type
OBSERVATIONAL
Enrollment
3,421
Safety and effectiveness data collection in connection with the use of the drug.
Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.
Unnamed facility
Skopje, North Macedonia
Incidence of serious adverse drug reactions (SADRs)
Time frame: after 26 weeks
Number of all minor hypoglycaemic events
Time frame: during 4 weeks preceding each visit
Number of all major hypoglycaemic events
Time frame: during 13 weeks preceding each visit
HbA1c
Time frame: after 26 weeks
Percentage of subjects to reach HbA1c below 7.0%
Time frame: after 13 weeks and 26 weeks
The effect on glycaemic control as measured by FPG (fasting plasma glucose)
Time frame: after 13 weeks and 26 weeks
The effect on glycamic control as measured by PG profile
Time frame: after 13 weeks and 26 weeks
Change in body weight
Time frame: after 13 weeks and 26 weeks
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