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

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: Insulin degludec /insulin aspart

Study type: Observational

Funder types: Industry

Identifiers

NCT03416855

1111-1194-8505 (Other Identifier)

NN5401-4196

Details and patient eligibility

About

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 practice conditions with the aim of identifying or quantifying a safety hazard, early detection of unknown safety problems. Participants will attend the clinic/hospital/medical institution according to usual practice and receive medical care, as agreed with the study doctor.

Enrollment: 768 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - 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 Criteria: - 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

Trial design

768 participants in 1 patient group

Overall population

Description:

Participants will be decided to be treated with Ryzodeg® FlexTouch® by physicians before the enrolment in the study based on clinical judgement in the diabetes management.

Treatment:

Drug: Insulin degludec /insulin aspart