Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®

Novo Nordisk

Status: Completed

Conditions: Diabetes

Treatments: Drug: insulin degludec/insulin aspart

Study type: Observational

Funder types: Industry

Identifiers

NCT02821052

U1111-1149-9518 (Other Identifier)

NN5401-4152

Details and patient eligibility

About

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.

Enrollment: 1,355 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,355 participants in 1 patient group

insulin degludec/insulin aspart

Treatment:

Drug: insulin degludec/insulin aspart