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

• Status: Completed
• Trial end date: 2018-11-24
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

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