Switching a DPP‑4 drug to a TZD for adults on metformin plus an SGLT2 inhibitor
A Randomized, Open-label, Active-controlled, Parallel, Multicenter, Phase IV Clinical Trial to Compare the Efficacy and Safety of Switching Metformin+SGLT2-i+Dipeptidyl Peptidase-4-inhibitor(DPP-4-i) to Metformin+SGLT2-i+TZD in Patients With Type 2 Diabetes
This trial tests whether switching the DPP‑4 pill to a thiazolidinedione (TZD) helps adults with type 2 diabetes who are already taking metformin and an SGLT2 inhibitor.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Seoul, Seocho District) |
| Trial ID | NCT06972732 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label, active-controlled, parallel, multicenter Phase IV trial comparing continued metformin + SGLT2 inhibitor + DPP‑4 inhibitor versus switching the DPP‑4 inhibitor to a TZD in adults with type 2 diabetes. Participants will be allocated to treatment groups and followed for measures of glycemic control and safety events. The main goals are to compare efficacy (for example, blood glucose control) and adverse effects between the two combination regimens. Standard clinical monitoring and laboratory tests will be used to detect benefits and harms.
Who should consider this trial
Good fit: Adults (age 19+) with type 2 diabetes who are currently taking metformin plus an SGLT2 inhibitor and a DPP‑4 inhibitor and who can safely switch medications are the ideal candidates.
Not a fit: Patients with type 1 diabetes, severe renal or liver disorders, recent participation in other investigational drug trials, or other contraindications to TZDs are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, switching to a TZD could improve blood sugar control or durability of response for some patients without unacceptable side effects.
How similar studies have performed: Previous trials of TZDs such as pioglitazone have shown improved insulin sensitivity and glycemic control, though they are associated with known risks like weight gain and edema.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Has voluntarily agreed to participate in this clinical trial. * Adults over 19 years of age * Diagnosed with type 2 diabetes Exclusion Criteria: * Has severe renal and liver disorders * Has type 1 diabetes * Those who are participating or have participated in other clinical trials and administered their investigational products within 8 weeks before the screening date for this study * Those who are deemed ineligible to participate in the study by the investigator
Where this trial is running
Seoul, Seocho District
- The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul, Seocho District, South Korea (Recruiting)
Study contacts
- Study coordinator: Oh
- Email: syoh@boryung.co.kr
- Phone: +82 2-708-8000
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.