Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGinsulin degludec
Frequency and timing of visits are based on normal clinical practice for patients with diabetes mellitus requiring insulin therapy.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with diabetes mellitus requiring insulin therapy for whom the treating physician has decided to start Tresiba® treatment
Exclusion criteria
* Patients who are or have previously been on Tresiba® therapy * Patients who have previously been participating in this PMS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AEs (Adverse Events) by preferred term | During 3 years of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of AEs (Adverse Events) by preferred term | During 6 months of treatment |
| Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term | During 6 months of treatment |
| Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term | During 6 months of treatment |
| Incidence of severe hypoglycaemia | During 6 months of treatment |
Countries
Japan
Outcome results
None listed