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

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: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes; Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Insulin degludec /insulin aspart

• Study Type: Observational
• Enrollment (Actual): 768

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number of Adverse events (AEs) at week 13	Count of events	week 13 (± 2 weeks)
Number of patients with AEs at week 13	Number of patients	week 13 (± 2 weeks)
Percentage of patients with AEs at week 13	Percentage of patients	week 13 (± 2 weeks)
Number of Adverse events (AEs) at week 26	Count of events	week 26 (± 2 weeks)
Number of patients with AEs at week 26	Number of patients	week 26 (± 2 weeks)
Percentage of patients with AEs at week 26	Percentage of patients	week 26 (± 2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Adverse Drug Reaction (ADR) at week 13	Number of patients	week 13 (± 2 weeks)
Percentage of Patients with ADR at week 13	Percentage of patients	week 13 (± 2 weeks)
Number of Patients with ADR at week 26	Number of patients	week 26 (± 2 weeks)
Percentage of Patients with ADR at week 26	Percentage of patients	week 26 (± 2 weeks)
Number of patients with Serious AE/ADR at week 13	Number of patients	week 13 (± 2 weeks)
Percentage of patients with Serious AE/ADR at week 13	Percentage of patients	week 13 (± 2 weeks)
Number of patients with Serious AE/ADR at week 26	Number of patients	week 26 (± 2 weeks)
Percentage of patients with Serious AE/ADR at week 26	Percentage of patients	week 26 (± 2 weeks)
Number of patients with unexpected ADR at week 13	Number of patients	week 13 (± 2 weeks)
Percentage of patients with unexpected ADR at week 13	Percentage of patients	week 13 (± 2 weeks)
Number of subjects with unexpected ADR at week 26	Number of subjects	week 26 (± 2 weeks)
Percentage of patients with unexpected ADR at week 26	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	Number of patients	week 13 (± 2 weeks)
Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13	Percentage of patients	week 13 (± 2 weeks)
Number of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26	Number of patients	week 26 (± 2 weeks)
Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26	Percentage of patients	week 26 (± 2 weeks)
Change from baseline in body weight at week 13	Measured in kg	week 0, week 13 (± 2 weeks)
Change from baseline in body weight at week 26	Measured in kg	week 0, week 26 (± 2 weeks)
Insulin dose at week 13	Dose in Units	week 13 (± 2 weeks)
Insulin dose at week 26	Dose in Units	week 26 (± 2 weeks)
Change from baseline in HbA1c after 13 weeks of treatment	Measured in %	week 0, week 13 (± 2 weeks)
Change from baseline in HbA1c after 26 weeks of treatment	Measured in %	week 0, week 26 (± 2 weeks)
Percentage of patients achieving the target of HbA1c < 7.0% at 13 weeks of treatment	Percentage of patients	week 13 (± 2 weeks)
Percentage of patients achieving the target of HbA1c < 7.0% at 26 weeks of treatment	Percentage of patients	week 26 (± 2 weeks)
Change from baseline in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) after 13 weeks treatment	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	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	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	Measured in mg/dl or other equivalent SI units	week 0, week 26 (± 2 weeks)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Actual): May 19, 2020
• Study Completion (Actual): May 19, 2020

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin Aspart
• Other Study ID 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