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

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin degludec

• Registration Number: NCT01984372
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-06
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-14
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6163

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tresiba® users	insulin degludec	-

Primary Outcome Measures

Name	Time	Method
Incidence of AEs (Adverse Events) by preferred term	During 3 years of treatment

Secondary Outcome Measures

Name	Time	Method
Incidence of severe hypoglycaemia	During 3 years of treatment
Incidence of AEs (Adverse Events) 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
Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term	During 3 years of treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan