Clinical trial NCT03416855: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-01-31
Enrollment: 768
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Adverse events (AEs) at week 13
timeFrame: week 13 (± 2 weeks)
measure: Number of patients with AEs at week 13
timeFrame: week 13 (± 2 weeks)
measure: Percentage of patients with AEs at week 13
timeFrame: week 13 (± 2 weeks)
measure: Number of Adverse events (AEs) at week 26
timeFrame: week 26 (± 2 weeks)
measure: Number of patients with AEs at week 26
timeFrame: week 26 (± 2 weeks)
measure: Percentage of patients with AEs at week 26
timeFrame: week 26 (± 2 weeks)
Secondary outcomes:
measure: Number of patients with Adverse Drug Reaction (ADR) at week 13
timeFrame: week 13 (± 2 weeks)
measure: Percentage of Patients with ADR at week 13
timeFrame: week 13 (± 2 weeks)
measure: Number of Patients with ADR at week 26
timeFrame: week 26 (± 2 weeks)
measure: Percentage of Patients with ADR at week 26
timeFrame: week 26 (± 2 weeks)
measure: Number of patients with Serious AE/ADR at week 13
timeFrame: week 13 (± 2 weeks)
measure: Percentage of patients with Serious AE/ADR at week 13
timeFrame: week 13 (± 2 weeks)
measure: Number of patients with Serious AE/ADR at week 26
timeFrame: week 26 (± 2 weeks)
measure: Percentage of patients with Serious AE/ADR at week 26
timeFrame: week 26 (± 2 weeks)
measure: Number of patients with unexpected ADR at week 13
timeFrame: week 13 (± 2 weeks)
measure: Percentage of patients with unexpected ADR at week 13
timeFrame: week 13 (± 2 weeks)
measure: Number of subjects with unexpected ADR at week 26
timeFrame: week 26 (± 2 weeks)
measure: Percentage of patients with unexpected ADR at week 26
timeFrame: week 26 (± 2 weeks)
measure: Number of patients with Severe or Blood Glucose (BG) confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13
timeFrame: week 13 (± 2 weeks)
measure: Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13
timeFrame: week 13 (± 2 weeks)
measure: Number of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26
timeFrame: week 26 (± 2 weeks)
measure: Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26
timeFrame: week 26 (± 2 weeks)
measure: Change from baseline in body weight at week 13
timeFrame: week 0, week 13 (± 2 weeks)
measure: Change from baseline in body weight at week 26
timeFrame: week 0, week 26 (± 2 weeks)
measure: Insulin dose at week 13
timeFrame: week 13 (± 2 weeks)
measure: Insulin dose at week 26
timeFrame: week 26 (± 2 weeks)
measure: Change from baseline in HbA1c after 13 weeks of treatment
timeFrame: week 0, week 13 (± 2 weeks)
measure: Change from baseline in HbA1c after 26 weeks of treatment
timeFrame: week 0, week 26 (± 2 weeks)
measure: Percentage of patients achieving the target of HbA1c < 7.0% at 13 weeks of treatment
timeFrame: week 13 (± 2 weeks)
measure: Percentage of patients achieving the target of HbA1c < 7.0% at 26 weeks of treatment
timeFrame: week 26 (± 2 weeks)
measure: Change from baseline in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) after 13 weeks treatment
timeFrame: week 0, week 13 (± 2 weeks)
measure: Change from baseline in FBG/FPG after 26 weeks treatment
timeFrame: week 0, week 26 (± 2 weeks)
measure: Changes from baseline in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) after 13 weeks treatment
timeFrame: week 0, week 13 (± 2 weeks)
measure: Changes from baseline in PPBG/PPPG after 26 weeks treatment
timeFrame: week 0, week 26 (± 2 weeks)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daegu
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gangwon-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Goyang
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeonggi-Do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Incheon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Jeonju
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Jeonju
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Pusan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Suwon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Ulsan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: