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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03416855
• Other study ID #: NN5401-4196
• Secondary ID: 1111-1194-8505
• Status: Completed
• Start date: January 31, 2018
• Est. completion date: May 19, 2020

Study information

• Verified date: November 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 768
• Est. completion date: May 19, 2020
• Est. primary completion date: May 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Daegu
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Gangwon-do
Korea, Republic of	Novo Nordisk Investigational Site	Goyang
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-Do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Incheon
Korea, Republic of	Novo Nordisk Investigational Site	Jeonju
Korea, Republic of	Novo Nordisk Investigational Site	Jeonju
Korea, Republic of	Novo Nordisk Investigational Site	Pusan
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Suwon
Korea, Republic of	Novo Nordisk Investigational Site	Suwon-si, Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse events (AEs) at week 13	Count of events	week 13 (± 2 weeks)
Primary	Number of patients with AEs at week 13	Number of patients	week 13 (± 2 weeks)
Primary	Percentage of patients with AEs at week 13	Percentage of patients	week 13 (± 2 weeks)
Primary	Number of Adverse events (AEs) at week 26	Count of events	week 26 (± 2 weeks)
Primary	Number of patients with AEs at week 26	Number of patients	week 26 (± 2 weeks)
Primary	Percentage of patients with AEs at week 26	Percentage of patients	week 26 (± 2 weeks)
Secondary	Number of patients with Adverse Drug Reaction (ADR) at week 13	Number of patients	week 13 (± 2 weeks)
Secondary	Percentage of Patients with ADR at week 13	Percentage of patients	week 13 (± 2 weeks)
Secondary	Number of Patients with ADR at week 26	Number of patients	week 26 (± 2 weeks)
Secondary	Percentage of Patients with ADR at week 26	Percentage of patients	week 26 (± 2 weeks)
Secondary	Number of patients with Serious AE/ADR at week 13	Number of patients	week 13 (± 2 weeks)
Secondary	Percentage of patients with Serious AE/ADR at week 13	Percentage of patients	week 13 (± 2 weeks)
Secondary	Number of patients with Serious AE/ADR at week 26	Number of patients	week 26 (± 2 weeks)
Secondary	Percentage of patients with Serious AE/ADR at week 26	Percentage of patients	week 26 (± 2 weeks)
Secondary	Number of patients with unexpected ADR at week 13	Number of patients	week 13 (± 2 weeks)
Secondary	Percentage of patients with unexpected ADR at week 13	Percentage of patients	week 13 (± 2 weeks)
Secondary	Number of subjects with unexpected ADR at week 26	Number of subjects	week 26 (± 2 weeks)
Secondary	Percentage of patients with unexpected ADR at week 26	Percentage of patients	week 26 (± 2 weeks)
Secondary	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)
Secondary	Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13	Percentage of patients	week 13 (± 2 weeks)
Secondary	Number of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26	Number of patients	week 26 (± 2 weeks)
Secondary	Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26	Percentage of patients	week 26 (± 2 weeks)
Secondary	Change from baseline in body weight at week 13	Measured in kg	week 0, week 13 (± 2 weeks)
Secondary	Change from baseline in body weight at week 26	Measured in kg	week 0, week 26 (± 2 weeks)
Secondary	Insulin dose at week 13	Dose in Units	week 13 (± 2 weeks)
Secondary	Insulin dose at week 26	Dose in Units	week 26 (± 2 weeks)
Secondary	Change from baseline in HbA1c after 13 weeks of treatment	Measured in %	week 0, week 13 (± 2 weeks)
Secondary	Change from baseline in HbA1c after 26 weeks of treatment	Measured in %	week 0, week 26 (± 2 weeks)
Secondary	Percentage of patients achieving the target of HbA1c < 7.0% at 13 weeks of treatment	Percentage of patients	week 13 (± 2 weeks)
Secondary	Percentage of patients achieving the target of HbA1c < 7.0% at 26 weeks of treatment	Percentage of patients	week 26 (± 2 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)