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

October 14, 2019 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1355

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 1000005
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
insulin degludec/insulin aspart
Drug: insulin degludec/insulin aspart
Enrolled patients will be treated with Ryzodeg® under routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of AEs (adverse event)
Time Frame: Year 0-1
Year 0-1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

November 24, 2018

Study Completion (Actual)

November 24, 2018

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-4152
  • U1111-1149-9518 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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