Evaluating the safety and effectiveness of triple therapy for Type 2 diabetes in Korean patients
A Multicenter, Prospective, Non-interventional Observation Study to Evaluate the Safety and Effectiveness of OAD Triple Therapy in Korean Type 2 Diabetic Mellitus Patients
This study is testing if a new combination of diabetes medications can help Korean patients with Type 2 diabetes who aren't getting good results from their current treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Chong Kun Dang Pharmaceutical Industry-sponsored |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT06838286 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include Korean adults aged 19 and older with Type 2 diabetes who have inadequate glycemic control on existing oral hypoglycemic therapy.
Not a fit: Patients with Type 1 diabetes, secondary diabetes, or those requiring insulin therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment options for managing Type 2 diabetes in patients who struggle with glycemic control.
How similar studies have performed: Other studies have shown promising results with similar triple therapy approaches in managing Type 2 diabetes, indicating potential for success in this observational study.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seongnam-si, Gyeonggi-do
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.