About this trial
The aim of this study is to assess the safety and effectiveness of Rybelsus initiated according to label in adults with Type 2 Diabetes Mellitus (T2DM) under routine clinical practice conditions. Participants will get Rybelsus as prescribed by study doctor. The study will last for about 26 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The decision to initiate treatment with commercially available Rybelsus has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
The participant with T2DM is scheduled to start treatment with Rybelsus based on the clinical judgment of their treating physician as specified in the approved label in Korea
Informed consent is 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
Male/female age greater than or equal to (>=) 19 years at the time of signing informed consent
Disqualifiers
Participants who are or have previously been on Rybelsus therapy
Known or suspected hypersensitivity to Rybelsus, 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 participant who is pregnant, breast-feeding or intends to become pregnant and is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by Korea regulation or practice)
Trial population
Adult participants with T2DM, who initiate treatment with Rybelsus under routine clinical practice in Korea.
Trial design
Cohort
Prospective
Treatments tested in this trial
Semaglutide
DrugAll participants will be treated with oral semaglutide for 26 weeks according to routine clinical practice at the discretion of the treating physician according to the label approved by MFDS. The prescription of semaglutide will be separated from the decision to include the participant in the study.
Treatment groups
Trial outcomes
Primary outcomes
Number (Incidence) of adverse events (AEs)
Measured as count of events.
Secondary outcomes
Number (Incidence) of hypoglycaemia Level 3 or Level 2
Hypoglycaemia Level 3 or Level 2 according to American Diabetes Association (ADA) guideline 2020 refers to: 1) Level 2: Glucose less than (\<) 54 milligrams per deciliter (mg/dL) (3.0 millimoles per liter \[mmol/L\]); 2) Level 3: A severe event characterized by altered mental and/or physical status requiring assistance for treatment of hypoglycaemia. Measured as count of events.
Change in glycated haemoglobin (HbA1c)
Measured in percentage (%).
Participants achieving HbA1c target <7.0%
Measured as count of participants (Yes/No).
Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG)
Measured in mg/dL.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: