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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821052
• Other study ID #: NN5401-4152
• Secondary ID: U1111-1149-9518
• Status: Completed
• Start date: July 1, 2016
• Est. completion date: November 24, 2018

Study information

• Verified date: October 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This trial is conducted in Asia. The aim of this Non-interventional study is to investigate the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1355
• Est. completion date: November 24, 2018
• Est. primary completion date: November 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 Ryzodeg® 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

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

• Male or female, no age limitation

Exclusion Criteria:

• Patients who are or have previously been treated with Ryzodeg®

• Previous participation in this study. Participation is defined as having given informed consent in this study

• Patients with a history of hypersensitivity to study product components

• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• insulin degludec/insulin aspart
Enrolled patients will be treated with Ryzodeg® under routine clinical practice.

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AEs (adverse event)		Year 0-1
Secondary	Incidence of SADRs (Serious Adverse Drug Reactions)		Year 0-1
Secondary	Severe hypoglycaemic episodes		Year 0-1
Secondary	Incidence of Serious allergic reactions (systemic or localized, including injection site reactions)		Year 0-1
Secondary	Change in Glycosylated haemoglobin A1c (HbA1c)		Week 0, week 52

External Links

•   Clinical Trials at Novo Nordisk