Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®
2 other identifiers
observational
1,355
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2016
Typical duration 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
First Submitted
Initial submission to the registry
June 29, 2016
CompletedFirst Posted
Study publicly available on registry
July 1, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2018
CompletedOctober 15, 2019
October 1, 2019
2.4 years
June 29, 2016
October 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of AEs (adverse event)
Year 0-1
Secondary Outcomes (4)
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
Study Arms (1)
insulin degludec/insulin aspart
Interventions
Enrolled patients will be treated with Ryzodeg® under routine clinical practice.
Eligibility Criteria
Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Tokyo, 1000005, Japan
Related Publications (1)
Katabami T, Eriksen KT, Yamamoto Y, Ishigaki Y. Long-Term Safety and Clinical Outcomes with Insulin Degludec/Insulin Aspart Treatment in Japanese Patients with Diabetes: A Real-World, Prospective, Observational Study. Adv Ther. 2022 Jan;39(1):544-561. doi: 10.1007/s12325-021-01978-2. Epub 2021 Nov 20.
PMID: 34800283DERIVED
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
June 29, 2016
First Posted
July 1, 2016
Study Start
July 1, 2016
Primary Completion
November 24, 2018
Study Completion
November 24, 2018
Last Updated
October 15, 2019
Record last verified: 2019-10