Regulatory Post Marketing Surveillance (rPMS) Study of Rybelsus (Oral Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19+
SponsorNovo Nordisk A/S

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Semaglutide

    Drug

    All 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

600 Participants
are divided into 1 treatment group
Group A: Participants with T2DM1 intervention

Trial outcomes

Primary outcomes

1

Number (Incidence) of adverse events (AEs)

Measured as count of events.

Time frame
From baseline (week 0) to 26 weeks

Secondary outcomes

1

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.

Time frame
From baseline (week 0) to 26 weeks
2

Change in glycated haemoglobin (HbA1c)

Measured in percentage (%).

Time frame
From baseline (week 0) to 26 weeks
3

Participants achieving HbA1c target <7.0%

Measured as count of participants (Yes/No).

Time frame
At 26 weeks
4

Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG)

Measured in mg/dL.

Time frame
From baseline (week 0) to 26 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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