← Back to all trials
Recruiting
NCT06838286
Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes
Conditions: Diabetes Mellitus, Type 2
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Enrollment: 10000
Sponsor: Chong Kun Dang Pharmaceutical
Location: Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
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 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.
Source: ClinicalTrials.gov (NCT06838286). StuddyBuddy aggregates publicly available trial information.