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

December 6, 2019 updated by: Novo Nordisk A/S

A Prospective Non-interventional Study Investigating the Treatment Effect of Switching From Insulin Glargine to Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real World Adult Population With Type 2 Diabetes in Japan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

246

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
      • Arakawa-ku, Tokyo, Japan, 116-0012
        • Novo Nordisk Investigational Site
      • Chuo-ku, Tokyo, Japan, 103-0002
        • Novo Nordisk Investigational Site
      • Fukuoka-shi, Fukuoka, Japan, 819-0006
        • Novo Nordisk Investigational Site
      • Fukushima, Japan, 963-8851
        • Novo Nordisk Investigational Site
      • Higashiosaka-shi, Osaka, Japan
        • Novo Nordisk Investigational Site
      • Hokkaido, Japan, 062-0007
        • Novo Nordisk Investigational Site
      • Hosu-gun, Ishikawa, Japan, 927-0053
        • Novo Nordisk Investigational Site
      • Kanagawa, Japan, 235-0045
        • Novo Nordisk Investigational Site
      • Kanagawa, Japan, 247-0055
        • Novo Nordisk Investigational Site
      • Kawagoe-shi, Saitama, Japan, 350-0851
        • Novo Nordisk Investigational Site
      • Kawaguchi-shi, Saitama, Japan, 332-0012
        • Novo Nordisk Investigational Site
      • Kisarazu-shi, Chiba, Japan, 292-0038
        • Novo Nordisk Investigational Site
      • Kita-ku, Tokyo, Japan, 114-0001
        • Novo Nordisk Investigational Site
      • Nagano, Japan, 390-8621
        • Novo Nordisk Investigational Site
      • Saitama-shi, Saitama, Japan, 336-0963
        • Novo Nordisk Investigational Site
      • Sapporo-shi, Hokkaido, Japan, 060-0001
        • Novo Nordisk Investigational Site
      • Sendai-shi, Miyagi, Japan, 980-0021
        • Novo Nordisk Investigational Site
      • Shimotsuga-gun, Tochigi, Japan, 321-0204
        • Novo Nordisk Investigational Site
      • Shimotsuke-shi, Tochigi, Japan, 329-0433
        • Novo Nordisk Investigational Site
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Novo Nordisk Investigational Site
      • Shizuoka-city, Shizuoka, Japan, 420-8630
        • Novo Nordisk Investigational Site
      • Shizuoka-shi, Shizuoka, Japan, 424-0853
        • Novo Nordisk Investigational Site
      • Shizuoka-shi, Shizuoka, Japan, 420-0923
        • Novo Nordisk Investigational Site
      • Tochigi, Japan, 323-0022
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 113-8431
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 143-8541
        • Novo Nordisk Investigational Site
      • Tsuchiura-shi,Ibaraki, Japan, 300-0062
        • Novo Nordisk Investigational Site
      • Yaizu-shi, Shizuoka, Japan, 425-0022
        • Novo Nordisk Investigational Site
      • Yokohama-shi, Kanagawa, Japan, 223-0066
        • 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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with type 2 diabetes requiring insulin therapy

Description

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®

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
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)
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in local laboratory measured glycosylated haemoglobin (HbA1c)
Time Frame: From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study visit or at discontunuation (-2 to +8 weeks at 26 weeks)
Measured in %point
From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study visit or at discontunuation (-2 to +8 weeks at 26 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total insulin dose
Time Frame: From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Measured in units/day
From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Change in basal insulin dose
Time Frame: From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Measured in units/day
From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Change in prandial insulin dose
Time Frame: From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Measured in units/day
From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Change in local laboratory measured fasting plasma glucose (FPG)
Time Frame: From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study (-2 to +8 weeks at 26 weeks)
Measured in mg/dL
From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study (-2 to +8 weeks at 26 weeks)
The incidence of patient recollection of non-severe hypoglycaemic episodes
Time Frame: Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Measured in episodes/person-year
Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
The incidence of patient recollection of nocturnal non-severe hypoglycaemic episodes
Time Frame: Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Measured in episodes/person-year
Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
The incidence of patient recollection of overall severe hypoglycaemic episodes
Time Frame: Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Measured in episodes/person-year
Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
The incidence of patient recollection of nocturnal severe hypoglycaemic episodes
Time Frame: Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Measured in episodes/person-year
Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Change in selected patient reported outcomes: Diabetes Therapy Related Quality of Life (DTR-QoL)
Time Frame: From baseline to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks). Baseline defined as visit 1 (week 0)
Score (on a scale from 0-100, where 100 is the highest health related quality of life (HRQoL))
From baseline to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks). Baseline defined as visit 1 (week 0)

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

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)

November 21, 2018

Primary Completion (Actual)

October 29, 2019

Study Completion (Actual)

October 29, 2019

Study Registration Dates

First Submitted

November 14, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 19, 2018

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-4441
  • U1111-1208-5143 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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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