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

Completed

• Conditions: Diabetes
• Interventions: Drug: insulin degludec/insulin aspart

• Registration Number: NCT02821052
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-06-29
• Study Start: 2016-07-01
• Study First Posted: 2016-07-01
• Primary Completion: 2018-11-24
• Study Completion: 2018-11-24
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1355

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
insulin degludec/insulin aspart	insulin degludec/insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Incidence of AEs (adverse event)	Year 0-1

Secondary Outcome Measures

Name	Time	Method
Incidence of SADRs (Serious Adverse Drug Reactions)	Year 0-1
Severe hypoglycaemic episodes	Year 0-1
Incidence of Serious allergic reactions (systemic or localized, including injection site reactions)	Year 0-1
Change in Glycosylated haemoglobin A1c (HbA1c)	Week 0, week 52

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan