Overview

A Study to Evaluate Safety and Effectiveness in Patients of All Age Groups Excluding Less Than 12 Months Old Infants With Diabetes Mellitus in Routine Clinical Practice in Korea

Status:
Completed
Trial end date:
2019-06-24
Target enrollment:
0
Participant gender:
All
Summary
This study is conducted in Asia. The aim of the study is to evaluate safety and effectiveness in patients of all age groups excluding less than 12 month old infants with diabetes mellitus in routine clinical practice in Korea.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
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 Tresiba®
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 - Male or Female, Age at least 12 months, at the time of signing informed
consent with type 1 or type 2 diabetes mellitus and who is scheduled to start treatment
with Tresiba® FlexTouch® based on the clinical judgment of their treating physician as
specified in the Korean-Prescribing Information (KPI) Exclusion Criteria: - Previous
participation in this study. Participation is defined as having given informed consent in
this study - Patients who are or have previously treated with Tresiba® FlexTouch® - Mental
incapacity, unwillingness or language barriers precluding adequate understanding or
cooperation. However, paediatric patients can be enrolled when the patient's primary
caregiver (e.g. parents) or legally acceptable representatives (LAR) are capable of giving
study specific signed informed consent. Any chronic disorder or severe disease which in the
opinion of the investigator might jeopardise patient's safety or compliance with the
protocol - Female who is pregnant, breast-feeding or intends to become pregnant and is of
child-baring potential and not using adequate contraceptive methods (adequate contraceptive
measures as required by local regulation or practice)