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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1355 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2018-11-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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insulin degludec/insulin aspart

Intervention Type DRUG

Enrolled patients will be treated with Ryzodeg® under routine clinical practice.

Interventions

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insulin degludec/insulin aspart

Enrolled patients will be treated with Ryzodeg® under routine clinical practice.

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No