Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGInsulin degludec /insulin aspart
Commercially available Insulin degludec /insulin aspart (Ryzodeg® FlexTouch®) according to routine clinical practice at the discretion of the treating physician.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse events (AEs) at week 13 | week 13 (± 2 weeks) | Count of events |
| Number of patients with AEs at week 13 | week 13 (± 2 weeks) | Number 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 |
| Number of patients with AEs at week 26 | week 26 (± 2 weeks) | Number of patients |
| Percentage of patients with AEs at week 26 | week 26 (± 2 weeks) | Percentage of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Serious AE/ADR at week 26 | week 26 (± 2 weeks) | Number of patients |
| Percentage of patients with Serious AE/ADR at week 26 | week 26 (± 2 weeks) | Percentage 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 subjects with unexpected ADR at week 26 | week 26 (± 2 weeks) | Number of subjects |
| Percentage of patients with unexpected ADR at week 26 | week 26 (± 2 weeks) | Percentage of patients |
| 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 Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) 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 patients with Adverse Drug Reaction (ADR) 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 |
| 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 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 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 13 | week 0, week 13 (± 2 weeks) | Measured in kg |
| 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 |
| Change from baseline in HbA1c after 13 weeks of treatment | week 0, week 13 (± 2 weeks) | Measured in % |
| Change from baseline in HbA1c after 26 weeks of treatment | week 0, week 26 (± 2 weeks) | Measured in % |
| 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 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 |
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed