Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Tresiba®
Status:
Completed
Trial end date:
2019-04-30
Target enrollment:
Participant gender:
Summary
This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to
assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in
patients with diabetes mellitus requiring insulin therapy under normal clinical practice
conditions.
A total of 4000 patients will be enrolled to investigate long term (3 years of treatment)
safety of Tresiba® and additional 2000 patients will be enrolled to assess the safety in an
early stage of the PMS more precisely. At the time of enrolment the patients will be randomly
allocated to either 3 years or 6 months observation group.