Clinical trial NCT05714683: 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
Official title: A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-02-06
Enrollment: 600
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult participants with T2DM, who initiate treatment with Rybelsus under routine clinical practice in Korea.

Brief summary: 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: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Family or personal history of multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC)

Primary outcomes:
measure: Number (Incidence) of adverse events (AEs)
timeFrame: From baseline (week 0) to 26 weeks
Secondary outcomes:
measure: Number (Incidence) of hypoglycaemia Level 3 or Level 2
timeFrame: From baseline (week 0) to 26 weeks
measure: Change in glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to 26 weeks
measure: Participants achieving HbA1c target <7.0%
timeFrame: At 26 weeks
measure: Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG)
timeFrame: From baseline (week 0) to 26 weeks
measure: Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG)
timeFrame: From baseline (week 0) to 26 weeks
measure: Change in body weight
timeFrame: From baseline (week 0) to 26 weeks
measure: Dose of Rybelsus
timeFrame: At 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: