This study is conducted in Asia. The aim of the study is to evaluate safety and effectiveness in patients of all age groups excluding less than 12 month old infants with diabetes mellitus in routine clinical practice in Korea.
Study Type
OBSERVATIONAL
Enrollment
3,303
Patients will be treated with commercially available Tresiba® FlexTouch® according to routine clinical practice at the discretion of the treating physician.
Number of Adverse Events (AE)
Time frame: Week 13± 2 weeks
Number of Adverse Events (AE)
Time frame: week 26± 2 weeks
Insulin dose changes
Time frame: Week 0, Week 26
Change in HbA1c
Time frame: Week 0, week 13, week 26
Percentage of patients achieving the target of HbA1c below 7.0%
Time frame: At week 13
Percentage of patients achieving the target of HbA1c below 7.0%
Time frame: At week 26
Change in fasting plasma glucose (FPG)
Time frame: Week 0, week 13, week 26
Changes in postprandial plasma glucose (PPG)
Time frame: Week 0, week 13, week 26
Number of Adverse reactions (AR)
Time frame: Week 13± 2 weeks
Number of Adverse reactions (AR)
Time frame: week 26± 2 weeks
Number of Serious AE
Time frame: Week 13± 2 weeks
Number of Serious AE
Time frame: week 26± 2 weeks
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Novo Nordisk Investigational Site
Bucheon-si, South Korea
Novo Nordisk Investigational Site
Busan, South Korea
Novo Nordisk Investigational Site
Busan, South Korea
Novo Nordisk Investigational Site
Busan, South Korea
Novo Nordisk Investigational Site
Busan, South Korea
Novo Nordisk Investigational Site
Busan, South Korea
Novo Nordisk Investigational Site
Chungcheongnam-do, South Korea
Novo Nordisk Investigational Site
Daegu, South Korea
Novo Nordisk Investigational Site
Daegu, South Korea
Novo Nordisk Investigational Site
Daejeon, South Korea
...and 34 more locations
Number of Serious AR
Time frame: Week 13± 2 weeks
Number of Serious AR
Time frame: week 26± 2 weeks
Number of Unexpected AR
Time frame: Week 13± 2 weeks
Number of Unexpected AR
Time frame: week 26± 2 weeks
Number of Severe hypoglycaemia (PG (plasma glucose) below 56 mg/dl)
Time frame: Week 13± 2 weeks
Number of Severe hypoglycaemia (PG (plasma glucose) below 56 mg/dl)
Time frame: week 26± 2 weeks
Number of Blood glucose (BG) confirmed hypoglycaemia (PG below 56 mg/dl)
Time frame: Week 13± 2 weeks
Number of Blood glucose (BG) confirmed hypoglycaemia (PG below 56 mg/dl)
Time frame: week 26± 2 weeks
Weight gain
Time frame: week 13 ± 2 weeks
Weight gain
Time frame: week 26± 2 weeks