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

Novo Nordisk A/S768 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

768

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

Insulin degludec /insulin aspartDRUG

Commercially available Insulin degludec /insulin aspart (Ryzodeg® FlexTouch®) according to routine clinical practice at the discretion of the treating physician.

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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

Locations (27)

Novo Nordisk Investigational Site

Busan, South Korea

Novo Nordisk Investigational Site

Busan, South Korea

Novo Nordisk Investigational Site

Busan, South Korea

Novo Nordisk Investigational Site

Busan, South Korea

Novo Nordisk Investigational Site

Daegu, South Korea

Novo Nordisk Investigational Site

Daejeon, South Korea

Novo Nordisk Investigational Site

Daejeon, South Korea

Novo Nordisk Investigational Site

Daejeon, South Korea

Novo Nordisk Investigational Site

Gangwon-do, South Korea

Novo Nordisk Investigational Site

Goyang, South Korea

...and 17 more locations

Outcomes

Primary Outcomes

Number of Adverse events (AEs) at week 13

Count of events

Time frame: week 13 (± 2 weeks)

Number of patients with AEs at week 13

Number of patients

Time frame: week 13 (± 2 weeks)

Percentage of patients with AEs at week 13

Percentage of patients

Time frame: week 13 (± 2 weeks)

Number of Adverse events (AEs) at week 26

Count of events

Time frame: week 26 (± 2 weeks)

Number of patients with AEs at week 26

Number of patients

Time frame: week 26 (± 2 weeks)

Percentage of patients with AEs at week 26

Percentage of patients

Time frame: week 26 (± 2 weeks)

Secondary Outcomes

Number of patients with Adverse Drug Reaction (ADR) at week 13

Number of patients

Time frame: week 13 (± 2 weeks)

Percentage of Patients with ADR at week 13

Percentage of patients

Time frame: week 13 (± 2 weeks)

Number of Patients with ADR at week 26

Number of patients

Time frame: week 26 (± 2 weeks)

Percentage of Patients with ADR at week 26

Percentage of patients

Time frame: week 26 (± 2 weeks)

Number of patients with Serious AE/ADR at week 13

Number of patients

Time frame: week 13 (± 2 weeks)

Percentage of patients with Serious AE/ADR at week 13

Percentage of patients

Time frame: week 13 (± 2 weeks)

Number of patients with Serious AE/ADR at week 26

Number of patients

Time frame: week 26 (± 2 weeks)

Percentage of patients with Serious AE/ADR at week 26

Percentage of patients

Time frame: week 26 (± 2 weeks)

Number of patients with unexpected ADR at week 13

Number of patients

Time frame: week 13 (± 2 weeks)

Percentage of patients with unexpected ADR at week 13

Percentage of patients

Time frame: week 13 (± 2 weeks)

Number of subjects with unexpected ADR at week 26

Number of subjects

Time frame: week 26 (± 2 weeks)

Percentage of patients with unexpected ADR at week 26

Percentage of patients

Time frame: 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

Time frame: week 13 (± 2 weeks)

Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13

Percentage of patients

Time frame: week 13 (± 2 weeks)

Number of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26

Number of patients

Time frame: week 26 (± 2 weeks)

Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26

Percentage of patients

Time frame: week 26 (± 2 weeks)

Change from baseline in body weight at week 13

Measured in kg

Time frame: week 0, week 13 (± 2 weeks)

Change from baseline in body weight at week 26

Measured in kg

Time frame: week 0, week 26 (± 2 weeks)

Insulin dose at week 13

Dose in Units

Time frame: week 13 (± 2 weeks)

Insulin dose at week 26

Dose in Units

Time frame: week 26 (± 2 weeks)

Change from baseline in HbA1c after 13 weeks of treatment

Measured in %

Time frame: week 0, week 13 (± 2 weeks)

Change from baseline in HbA1c after 26 weeks of treatment

Measured in %

Time frame: week 0, week 26 (± 2 weeks)

Percentage of patients achieving the target of HbA1c < 7.0% at 13 weeks of treatment

Percentage of patients

Time frame: week 13 (± 2 weeks)

Percentage of patients achieving the target of HbA1c < 7.0% at 26 weeks of treatment

Percentage of patients

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: week 0, week 26 (± 2 weeks)

Data from ClinicalTrials.gov

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