MedDataX Logo

RESILIENT: A Research Study, Looking at How Ryzodeg® Works in People With Type 2 Diabetes in Local Clinical Practice in Japan

NCT ID: NCT03745157

Last Updated: 2019-12-09

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-21

Study Completion Date

2019-10-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to collect information on how Ryzodeg® works in real world participants. Participants will get Ryzodeg® as prescribed to them by the study doctor. The study will last for about 6 to 8 months. The participants will be asked questions about their health and their diabetes treatment as part of their normal study doctor's appointment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with Type 2 Diabetes requiring insulin therapy

Patients with type 2 diabetes requiring insulin therapy in Japanese routine clinical practice previously treated with insulin glargine (IGlar)

Insulin Degludec/Insulin Aspart

Intervention Type DRUG

Patients will be treated with commercially available Insulin Degludec/Insulin Aspart (Ryzodeg®) in a pre-filled pen injector (FlexTouch®) according to routine clinical practice at the discretion of the treating physician in accordance with the Ryzodeg® label in Japan

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Insulin Degludec/Insulin Aspart

Patients will be treated with commercially available Insulin Degludec/Insulin Aspart (Ryzodeg®) in a pre-filled pen injector (FlexTouch®) according to routine clinical practice at the discretion of the treating physician in accordance with the Ryzodeg® label in Japan

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol
* The decision to initiate treatment with commercially available insulin Ryzodeg® has been made by the patient/legally acceptable representative and the treating physician before and independently from the decision to include the patient in this study
* Male or female, age more than or equal to 20 years (the legal age of adulthood) at the time of signing informed consent
* Diagnosed with type 2 diabetes (T2D) for at least 26 weeks prior to signing informed consent
* Available and documented glycosylated haemoglobin (HbA1c) value less than or equal to 12 weeks prior to initiation of Ryzodeg® treatment
* For at least 26 weeks prior to initiation of Ryzodeg® treatment, one of the following must apply: A) Treated with insulin glargine (IGlar) (any formulation, including biosimilar IGlar). B) Treated with IGlar (any formulation, including biosimilar IGlar) and IGlar U300 for at least 12 weeks prior to initiation of Ryzodeg®

Exclusion Criteria

* Previous participation in this study. Participation is defined as signed informed consent.
* Pregnancy
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Hypersensitivity to Ryzodeg® or to any of the excipients
* Previously treated with Ryzodeg®
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Arakawa-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Fukuoka-shi, Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Fukushima, , Japan

Site Status

Novo Nordisk Investigational Site

Higashiosaka-shi, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Hosu-gun, Ishikawa, , Japan

Site Status

Novo Nordisk Investigational Site

Kanagawa, , Japan

Site Status

Novo Nordisk Investigational Site

Kanagawa, , Japan

Site Status

Novo Nordisk Investigational Site

Kawagoe-shi, Saitama, , Japan

Site Status

Novo Nordisk Investigational Site

Kawaguchi-shi, Saitama, , Japan

Site Status

Novo Nordisk Investigational Site

Kisarazu-shi, Chiba, , Japan

Site Status

Novo Nordisk Investigational Site

Kita-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Nagano, , Japan

Site Status

Novo Nordisk Investigational Site

Saitama-shi, Saitama, , Japan

Site Status

Novo Nordisk Investigational Site

Sapporo-shi, Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Sendai-shi, Miyagi, , Japan

Site Status

Novo Nordisk Investigational Site

Shimotsuga-gun, Tochigi, , Japan

Site Status

Novo Nordisk Investigational Site

Shimotsuke-shi, Tochigi, , Japan

Site Status

Novo Nordisk Investigational Site

Shinjuku-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Shizuoka-city, Shizuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Shizuoka-shi, Shizuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Shizuoka-shi, Shizuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Tochigi, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Tsuchiura-shi,Ibaraki, , Japan

Site Status

Novo Nordisk Investigational Site

Yaizu-shi, Shizuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Yokohama-shi, Kanagawa, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

Shigiyama F, Liu L, Nordahl H, Suzuki R, Yamamoto Y, Hirose T. A Real-World, Prospective, Non-interventional Study of Adults with T2D Switching to IDegAsp from Glargine U100 or U300 in Japan. Diabetes Ther. 2021 Sep;12(9):2405-2421. doi: 10.1007/s13300-021-01117-8. Epub 2021 Jul 25.

Reference Type DERIVED
PMID: 34304385 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1208-5143

Identifier Type: OTHER

Identifier Source: secondary_id

NN5401-4441

Identifier Type: -

Identifier Source: org_study_id