This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.
Study Type
OBSERVATIONAL
Enrollment
216
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Unnamed facility
Tunisia, Tunisia
Incidence of major hypoglycaemic events reported as serious adverse drug reactions
Time frame: during 26 weeks of treatment
Number of serious adverse drug reactions
Time frame: during 26 weeks of treatment
Number of serious adverse events
Time frame: during 26 weeks of treatment
Number of all major (daytime and nocturnal) hypoglycaemic events
Time frame: during 26 weeks of treatment
Number of all minor (daytime and nocturnal) hypoglycaemic events
Time frame: during 26 weeks of treatment
Weight (BMI) change from baseline
Time frame: At the end of the study
HbA1c change from baseline
Time frame: At the end of the study
Percentage of patients reaching the target of HbA1c of less than or equal to 7.0%
Time frame: At the end of the study
Average (mean) fasting plasma glucose level
Time frame: At the end of the study
Average post-breakfast (90-120 mins), post-lunch (90-120 mins), post-dinner (90-120 mins) plasma glucose level
Time frame: At the end of the study
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