Thiazolidinedione: Thiazolidinedione class of drugs
DPP-4 inhibitor: DPP4 inhibitor class of drugs
Study summary
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
Eligibility
Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Safety Evaluation of Triple Combination Therapy with SGLT-2i, DPP-4i, or TZD Class Drugs, Including Metformin — Up to 24 months Safety will be assessed based on all adverse events, laboratory test results, and vital signs collected after enrollment during the study period.
Trial sites (1)
Facility
City
Region
Status
Seoul National University Bundang Hospital
Seongnam-si
Gyeonggi-do
Recruiting
More Chong Kun Dang Pharmaceutical trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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