Recruiting
Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
ClinicalTrials.gov IDNCT06838286
PhaseNot Applicable
Enrollment10000
SponsorChong Kun Dang Pharmaceutical
Age19 Years
SexALL
Conditions studied
Diabetes Mellitus, Type 2
About this study
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
Interventions
- Drug: SGLT2 inhibitor — SGLT2 inhibitor class of drugs
- Drug: Thiazolidinedione — Thiazolidinedione class of drugs
- Drug: DPP-4 inhibitor — DPP4 inhibitor class of drugs
Primary outcomes
- Evaluation of Incidence of Adverse events in Triple Combination Therapy Including Metformin with SGLT-2i, DPP-4i, or TZD Class Drugs. (24 month)
Eligibility information
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.
Study locations
- Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do South Korea
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.