Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes
Recruiting now
Conditions studied: Diabetes Mellitus, Type 2
In brief
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
Key facts
- Study ID
- NCT06838286
- Run by
- Chong Kun Dang Pharmaceutical
- People needed
- 10000
- Starts
- 2024-03-16
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2025-02-20
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with type 2 diabetes who are 19 years of age or older at the time of enrollment.
- Continued DPP-4i or SGLT-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment.
- 7.0% ≤ HbA1c < 10.0% based on laboratory tests performed within 4 weeks of enrollment.
- Voluntarily give written informed consent after being told about the study.
You may not qualify if…
- Patients with type 1 diabetes and secondary diabetes.
- Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment.
- Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study.
- End-stage renal disease and hemodialysis patients.
- diabetic ketoacidosis Patients.
- Pregnant and lactating women.
- 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.
- Patients with a history of hypersensitivity to the investigational drug or any of its components or excipients.
- Anyone else deemed by the investigator to be unsuitable for participation in the study.
Where it is running
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (enrolling)
Full record on ClinicalTrials.gov
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