Status:
COMPLETED
A Regulatory Post Marketing Surveillance (rPMS) Study of Ryzodeg® FlexTouch® (Insulin Degludec /Insulin Aspart) to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice in Korea
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
2+ years
Brief Summary
The purpose of this study is to collect information about safety and effectiveness of Ryzodeg® FlexTouch® in participants with diabetes mellitus requiring insulin therapy under routine clinical practi...
Eligibility Criteria
Inclusion
- The decision to initiate treatment with commercially available Ryzodeg® FlexTouch® 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 - Signed informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study - Age equals to or more than 2 years at the time of signing informed consent with diabetes mellitus (Type 1 or Type 2) and who is scheduled to start treatment with Ryzodeg® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (K-PI)
Exclusion
- Patients who are or have previously been on Ryzodeg® FlexTouch® therapy - Known or suspected hypersensitivity to Ryzodeg® FlexTouch®, the active substance or any of the excipients - Previous participation in this study. Participation is defined as having given informed consent in this study - Female patient who is pregnant, breast-feeding or intends to become pregnant and is of childbearing potential and not using adequate contraceptive methods(adequate contraceptive measures as required by Korea regulation or practice) - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Key Trial Info
Start Date :
January 31 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 19 2020
Estimated Enrollment :
768 Patients enrolled
Trial Details
Trial ID
NCT03416855
Start Date
January 31 2018
End Date
May 19 2020
Last Update
November 10 2021
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Novo Nordisk Investigational Site
Busan, South Korea, 47392
2
Novo Nordisk Investigational Site
Busan, South Korea, 48108
3
Novo Nordisk Investigational Site
Busan, South Korea, 48575
4
Novo Nordisk Investigational Site
Busan, South Korea, 49267