Evaluating the safety and effectiveness of triple therapy for Type 2 diabetes in Korean patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, non-interventional observational study aims to assess the safety and effectiveness of oral antidiabetic (OAD) triple therapy in Korean patients with Type 2 diabetes mellitus who have not achieved adequate glycemic control with conventional combination therapy. Participants will be prescribed a combination of SGLT-2 inhibitors, DPP-4 inhibitors, or thiazolidinediones based on the investigator's medical judgment. The study will monitor treatment outcomes and laboratory tests to evaluate the real-world effectiveness of this therapy in managing diabetes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with type 2 diabetes who are 19 years of age or older at the time of enrollment.
2. Continued DPP-4i or SGLT-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment.
3. 7.0% ≤ HbA1c \< 10.0% based on laboratory tests performed within 4 weeks of enrollment.
4. Voluntarily give written informed consent after being told about the study.

Exclusion Criteria:

1. Patients with type 1 diabetes and secondary diabetes.
2. Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment.
3. Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study.
4. End-stage renal disease and hemodialysis patients.
5. diabetic ketoacidosis Patients.
6. Pregnant and lactating women.
7. Patients who are contraindicated by any of the "Precautions for Use" in the license for the drug being administered during the study, given the observational nature of the study under routine practice.
8. Patients with a history of hypersensitivity to the investigational drug or any of its components or excipients.
9. Anyone else deemed by the investigator to be unsuitable for participation in the study.

Where it's running

• Seoul National University Bundang Hospital
  Seongnam-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Study coordinator: Soo Lim, M.D, Ph.D.
• Email: limsoo@snu.ac.kr
• Phone: 82-2-6373-0773

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.