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CompletedNCT02821052Updated Oct 15, 2019

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

An observational study in Diabetes, sponsored by Novo Nordisk A/S. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2019-10-15.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,355
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,355 participants (actual)
Patient registry
No

Groups and cohorts

  • insulin degludec/insulin aspart

    Drug: insulin degludec/insulin aspart

Interventions

  • Druginsulin degludec/insulin aspart

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

06

What researchers measure

Primary outcomes

  1. Incidence of AEs (adverse event)

    Time frame: Year 0-1

Secondary outcomes

  1. Incidence of SADRs (Serious Adverse Drug Reactions)

    Time frame: Year 0-1

  2. Severe hypoglycaemic episodes

    Time frame: Year 0-1

  3. Incidence of Serious allergic reactions (systemic or localized, including injection site reactions)

    Time frame: Year 0-1

  4. Change in Glycosylated haemoglobin A1c (HbA1c)

    Time frame: Week 0, week 52

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Tokyo, 1000005, Japan
08

References and documents

Publications

  • 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. PubMed 34800283 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02821052
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jul 1, 2016
Start date
Jul 1, 2016
Primary completion
Nov 24, 2018
Completion
Nov 24, 2018
Last update
Oct 15, 2019

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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