Diabetes
Conditions
Brief summary
This trial is conducted in Asia. The aim of this Non-interventional study is to investigate the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
Interventions
DRUGinsulin degludec/insulin aspart
Enrolled patients will be treated with Ryzodeg® under routine clinical practice.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * The decision to initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study * Patients with diabetes mellitus requiring insulin therapy for whom the physician has decided to start treatment with Ryzodeg® * Male or female, no age limitation
Exclusion criteria
* Patients who are or have previously been treated with Ryzodeg® * Previous participation in this study. Participation is defined as having given informed consent in this study * Patients with a history of hypersensitivity to study product components * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AEs (adverse event) | Year 0-1 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of SADRs (Serious Adverse Drug Reactions) | Year 0-1 |
| Severe hypoglycaemic episodes | Year 0-1 |
| Incidence of Serious allergic reactions (systemic or localized, including injection site reactions) | Year 0-1 |
| Change in Glycosylated haemoglobin A1c (HbA1c) | Week 0, week 52 |
Countries
Japan
Outcome results
None listed