Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Tresiba®
A Multi-centre, Open Label, Observational, Non-interventional, Post Marketing Surveillance to Evaluate Safety and Effectiveness During Long-term Treatment With Tresiba® (Insulin Degludec) in Patients With Diabetes Mellitus Requiring Insulin Therapy Under Normal Clinical Practice Conditions
2 other identifiers
observational
6,163
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 6, 2013
CompletedFirst Submitted
Initial submission to the registry
November 7, 2013
CompletedFirst Posted
Study publicly available on registry
November 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedAugust 4, 2020
August 1, 2020
5.5 years
November 7, 2013
August 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of AEs (Adverse Events) by preferred term
During 3 years of treatment
Secondary Outcomes (7)
Incidence of AEs (Adverse Events) by preferred term
During 6 months of treatment
Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term
During 6 months of treatment
Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term
During 3 years of treatment
Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term
During 6 months of treatment
Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term
During 3 years of treatment
- +2 more secondary outcomes
Study Arms (1)
Tresiba® users
Interventions
Frequency and timing of visits are based on normal clinical practice for patients with diabetes mellitus requiring insulin therapy.
Eligibility Criteria
Patients with diabetes mellitus requiring insulin therapy not previously treated with Tresiba®, including newly-diagnosed patients whom the physician has judged as appropriate to start treatment with Tresiba®.
You may qualify if:
- Patients with diabetes mellitus requiring insulin therapy for whom the treating physician has decided to start Tresiba® treatment
You may not qualify if:
- Patients who are or have previously been on Tresiba® therapy
- Patients who have previously been participating in this PMS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Tokyo, 1000005, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2013
First Posted
November 14, 2013
Study Start
November 6, 2013
Primary Completion
April 30, 2019
Study Completion
April 30, 2019
Last Updated
August 4, 2020
Record last verified: 2020-08