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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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05714683
Collaborator
(none)
600
Enrollment
44.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Jan 31, 2023
Anticipated Primary Completion Date :
Oct 30, 2026
Anticipated Study Completion Date :
Oct 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Participants with T2DM

All participants will be treated with Rybelsus for 26 weeks according to routine clinical practice at the discretion of the treating physician according to the label approved by Ministry of Food and Drug Safety (MFDS).

Drug: Semaglutide
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.
Other Names:
  • Rybelsus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number (Incidence) of adverse events (AEs) [From baseline (week 0) to 26 weeks]

      Measured as count of events.

    Secondary Outcome Measures

    1. Number (Incidence) of hypoglycaemia Level 3 or Level 2 [From baseline (week 0) to 26 weeks]

      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.

    2. Change in glycated haemoglobin (HbA1c) [From baseline (week 0) to 26 weeks]

      Measured in percentage (%).

    3. Participants achieving HbA1c target <7.0% [At 26 weeks]

      Measured as count of participants (Yes/No).

    4. Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG) [From baseline (week 0) to 26 weeks]

      Measured in mg/dL.

    5. Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG) [From baseline (week 0) to 26 weeks]

      Measured in mg/dL.

    6. Change in body weight [From baseline (week 0) to 26 weeks]

      Measured in kilogram (kg).

    7. Dose of Rybelsus [At 26 weeks]

      Measured in milligrams per day (mg/day).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Female
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Novo Nordisk A/S

    Investigators

    • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT05714683
    Other Study ID Numbers:
    • NN9924-4652
    • U1111-1243-9500
    First Posted:
    Feb 6, 2023
    Last Update Posted:
    Feb 6, 2023
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Feb 6, 2023