GLP-1 Peptide Atlas, by Delfa

Not yet recruiting

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

600

estimated

Study population

Type 2 diabetes

Key I/E criterion

•Female

Primary endpoint

•Treatment-emergent AEs (any)

Identifiers

Registered as

NCT IDNCT05714683

Org study IDNN9924-4652

Secondary IDU1111-1243-9500World Health Organization (WHO)

Timeline

Milestones

Study first posted2023-02-06actual

Last update posted2025-12-05actual

Study start2025-12-31estimated

Primary completion2026-10-30estimated

Study completion2026-10-30estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age19 Years

SexFemale

Sampling methodProbability sample

Study population text

Adult participants with T2DM, who initiate treatment with Rybelsus under routine clinical practice in Korea.

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)

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body weight

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

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants achieving HbA1c target <7.0%

Time frame:At 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

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

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG)

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

Postprandial glucose

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number (Incidence) of adverse events (AEs)

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

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number (Incidence) of hypoglycaemia Level 3 or Level 2

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

Severe hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Dose of Rybelsus

Time frame:At 26 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.