A Regulatory Post Marketing Surveillance (rPMS) Study of Ryzodeg® FlexTouch® (Insulin Degludec /Insulin Aspart) to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice in Korea

November 9, 2021 updated by: Novo Nordisk A/S

A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance(rPMS) Study of Ryzodeg® FlexTouch® (Insulin Degludec /Insulin Aspart) to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice in Korea

The purpose of this study is to collect information about safety and effectiveness of Ryzodeg® FlexTouch® in participants with diabetes mellitus requiring insulin therapy under routine clinical practice conditions with the aim of identifying or quantifying a safety hazard, early detection of unknown safety problems. Participants will attend the clinic/hospital/medical institution according to usual practice and receive medical care, as agreed with the study doctor.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
768

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

  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Novo Nordisk Investigational Site
      • Busan, Korea, Republic of, 49267
        • Novo Nordisk Investigational Site
      • Busan, Korea, Republic of, 48108
        • Novo Nordisk Investigational Site
      • Busan, Korea, Republic of, 48575
        • Novo Nordisk Investigational Site
      • Daegu, Korea, Republic of, 42601
        • Novo Nordisk Investigational Site
      • Daejeon, Korea, Republic of, 361-711
        • Novo Nordisk Investigational Site
      • Daejeon, Korea, Republic of, 330-721
        • Novo Nordisk Investigational Site
      • Daejeon, Korea, Republic of, 35015
        • Novo Nordisk Investigational Site
      • Gangwon-do, Korea, Republic of, 26426
        • Novo Nordisk Investigational Site
      • Goyang, Korea, Republic of, 410-719
        • Novo Nordisk Investigational Site
      • Gyeonggi-Do, Korea, Republic of, 14068
        • Novo Nordisk Investigational Site
      • Gyeonggi-do, Korea, Republic of, 14754
        • Novo Nordisk Investigational Site
      • Gyeonggi-do, Korea, Republic of, 10475
        • Novo Nordisk Investigational Site
      • Gyeonggi-do, Korea, Republic of, 14584
        • Novo Nordisk Investigational Site
      • Incheon, Korea, Republic of, 22332
        • Novo Nordisk Investigational Site
      • Jeonju, Korea, Republic of, 561-712
        • Novo Nordisk Investigational Site
      • Jeonju, Korea, Republic of, 54987
        • Novo Nordisk Investigational Site
      • Pusan, Korea, Republic of, 602-739
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 01450
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 139-827
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 04564
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 04401
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 05355
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 07354
        • Novo Nordisk Investigational Site
      • Suwon, Korea, Republic of, 16499
        • Novo Nordisk Investigational Site
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
        • Novo Nordisk Investigational Site
      • Ulsan, Korea, Republic of, 682-060
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diabetes mellitus, who are scheduled to start treatment with Ryzodeg® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information

Description

Inclusion Criteria: - The decision to initiate treatment with commercially available Ryzodeg® FlexTouch® 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 - Signed informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study - Age equals to or more than 2 years at the time of signing informed consent with diabetes mellitus (Type 1 or Type 2) and who is scheduled to start treatment with Ryzodeg® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (K-PI) Exclusion Criteria: - Patients who are or have previously been on Ryzodeg® FlexTouch® therapy - Known or suspected hypersensitivity to Ryzodeg® FlexTouch®, the active substance or any of the excipients - Previous participation in this study. Participation is defined as having given informed consent in this study - Female patient who is pregnant, breast-feeding or intends to become pregnant and is of childbearing potential and not using adequate contraceptive methods(adequate contraceptive measures as required by Korea regulation or practice) - 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Overall population
Participants will be decided to be treated with Ryzodeg® FlexTouch® by physicians before the enrolment in the study based on clinical judgement in the diabetes management.
Drug: Insulin degludec /insulin aspart
Commercially available Insulin degludec /insulin aspart (Ryzodeg® FlexTouch®) according to routine clinical practice at the discretion of the treating physician.
Other Names:
  • Ryzodeg® FlexTouch®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Adverse events (AEs) at week 13
Time Frame: week 13 (± 2 weeks)
Count of events
week 13 (± 2 weeks)
Number of patients with AEs at week 13
Time Frame: week 13 (± 2 weeks)
Number of patients
week 13 (± 2 weeks)
Percentage of patients with AEs at week 13
Time Frame: week 13 (± 2 weeks)
Percentage of patients
week 13 (± 2 weeks)
Number of Adverse events (AEs) at week 26
Time Frame: week 26 (± 2 weeks)
Count of events
week 26 (± 2 weeks)
Number of patients with AEs at week 26
Time Frame: week 26 (± 2 weeks)
Number of patients
week 26 (± 2 weeks)
Percentage of patients with AEs at week 26
Time Frame: week 26 (± 2 weeks)
Percentage of patients
week 26 (± 2 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients with Adverse Drug Reaction (ADR) at week 13
Time Frame: week 13 (± 2 weeks)
Number of patients
week 13 (± 2 weeks)
Percentage of Patients with ADR at week 13
Time Frame: week 13 (± 2 weeks)
Percentage of patients
week 13 (± 2 weeks)
Number of Patients with ADR at week 26
Time Frame: week 26 (± 2 weeks)
Number of patients
week 26 (± 2 weeks)
Percentage of Patients with ADR at week 26
Time Frame: week 26 (± 2 weeks)
Percentage of patients
week 26 (± 2 weeks)
Number of patients with Serious AE/ADR at week 13
Time Frame: week 13 (± 2 weeks)
Number of patients
week 13 (± 2 weeks)
Percentage of patients with Serious AE/ADR at week 13
Time Frame: week 13 (± 2 weeks)
Percentage of patients
week 13 (± 2 weeks)
Number of patients with Serious AE/ADR at week 26
Time Frame: week 26 (± 2 weeks)
Number of patients
week 26 (± 2 weeks)
Percentage of patients with Serious AE/ADR at week 26
Time Frame: week 26 (± 2 weeks)
Percentage of patients
week 26 (± 2 weeks)
Number of patients with unexpected ADR at week 13
Time Frame: week 13 (± 2 weeks)
Number of patients
week 13 (± 2 weeks)
Percentage of patients with unexpected ADR at week 13
Time Frame: week 13 (± 2 weeks)
Percentage of patients
week 13 (± 2 weeks)
Number of subjects with unexpected ADR at week 26
Time Frame: week 26 (± 2 weeks)
Number of subjects
week 26 (± 2 weeks)
Percentage of patients with unexpected ADR at week 26
Time Frame: week 26 (± 2 weeks)
Percentage of patients
week 26 (± 2 weeks)
Number of patients with Severe or Blood Glucose (BG) confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13
Time Frame: week 13 (± 2 weeks)
Number of patients
week 13 (± 2 weeks)
Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13
Time Frame: week 13 (± 2 weeks)
Percentage of patients
week 13 (± 2 weeks)
Number of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26
Time Frame: week 26 (± 2 weeks)
Number of patients
week 26 (± 2 weeks)
Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26
Time Frame: week 26 (± 2 weeks)
Percentage of patients
week 26 (± 2 weeks)
Change from baseline in body weight at week 13
Time Frame: week 0, week 13 (± 2 weeks)
Measured in kg
week 0, week 13 (± 2 weeks)
Change from baseline in body weight at week 26
Time Frame: week 0, week 26 (± 2 weeks)
Measured in kg
week 0, week 26 (± 2 weeks)
Insulin dose at week 13
Time Frame: week 13 (± 2 weeks)
Dose in Units
week 13 (± 2 weeks)
Insulin dose at week 26
Time Frame: week 26 (± 2 weeks)
Dose in Units
week 26 (± 2 weeks)
Change from baseline in HbA1c after 13 weeks of treatment
Time Frame: week 0, week 13 (± 2 weeks)
Measured in %
week 0, week 13 (± 2 weeks)
Change from baseline in HbA1c after 26 weeks of treatment
Time Frame: week 0, week 26 (± 2 weeks)
Measured in %
week 0, week 26 (± 2 weeks)
Percentage of patients achieving the target of HbA1c < 7.0% at 13 weeks of treatment
Time Frame: week 13 (± 2 weeks)
Percentage of patients
week 13 (± 2 weeks)
Percentage of patients achieving the target of HbA1c < 7.0% at 26 weeks of treatment
Time Frame: week 26 (± 2 weeks)
Percentage of patients
week 26 (± 2 weeks)
Change from baseline in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) after 13 weeks treatment
Time Frame: week 0, week 13 (± 2 weeks)
Measured in mg/dl or other equivalent SI units
week 0, week 13 (± 2 weeks)
Change from baseline in FBG/FPG after 26 weeks treatment
Time Frame: week 0, week 26 (± 2 weeks)
Measured in mg/dl or other equivalent SI units
week 0, week 26 (± 2 weeks)
Changes from baseline in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) after 13 weeks treatment
Time Frame: week 0, week 13 (± 2 weeks)
Measured in mg/dl or other equivalent SI units
week 0, week 13 (± 2 weeks)
Changes from baseline in PPBG/PPPG after 26 weeks treatment
Time Frame: week 0, week 26 (± 2 weeks)
Measured in mg/dl or other equivalent SI units
week 0, week 26 (± 2 weeks)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN5401-4196
  • 1111-1194-8505 (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 drug product

No

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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