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

Completed

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

• Registration Number: NCT03416855
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-24
• Study Start: 2018-01-31
• Study First Posted: 2018-01-31
• Primary Completion: 2020-05-19
• Study Completion: 2020-05-19
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 768

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)

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Overall population	Insulin degludec /insulin aspart	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.

Primary Outcome Measures

Name	Time	Method
Number of Adverse events (AEs) at week 13	week 13 (± 2 weeks)	Count of events
Number of patients with AEs at week 26	week 26 (± 2 weeks)	Number of patients
Number of patients with AEs at week 13	week 13 (± 2 weeks)	Number of patients
Percentage of patients with AEs at week 26	week 26 (± 2 weeks)	Percentage of patients
Percentage of patients with AEs at week 13	week 13 (± 2 weeks)	Percentage of patients
Number of Adverse events (AEs) at week 26	week 26 (± 2 weeks)	Count of events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇰🇷 Ulsan, Korea, Republic of