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

Novo Nordisk

Status: Completed

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

Treatments: Drug: insulin degludec

Study type: Observational

Funder types: Industry

Identifiers

NCT01984372

NN1250-4061

U1111-1144-4412 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 6,163 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with diabetes mellitus requiring insulin therapy for whom the treating physician has decided to start Tresiba® treatment

Exclusion criteria

• Patients who are or have previously been on Tresiba® therapy
• Patients who have previously been participating in this PMS

Trial design

6,163 participants in 1 patient group

Tresiba® users

Treatment:

Drug: insulin degludec