This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions. A total of 4000 patients will be enrolled to investigate long term (3 years of treatment) safety of Tresiba® and additional 2000 patients will be enrolled to assess the safety in an early stage of the PMS more precisely. At the time of enrolment the patients will be randomly allocated to either 3 years or 6 months observation group.
Study Type
OBSERVATIONAL
Enrollment
6,163
Frequency and timing of visits are based on normal clinical practice for patients with diabetes mellitus requiring insulin therapy.
Novo Nordisk Investigational Site
Tokyo, Japan
Incidence of AEs (Adverse Events) by preferred term
Time frame: During 3 years of treatment
Incidence of AEs (Adverse Events) by preferred term
Time frame: During 6 months of treatment
Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term
Time frame: During 6 months of treatment
Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term
Time frame: During 3 years of treatment
Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term
Time frame: During 6 months of treatment
Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term
Time frame: During 3 years of treatment
Incidence of severe hypoglycaemia
Time frame: During 6 months of treatment
Incidence of severe hypoglycaemia
Time frame: During 3 years of treatment
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