Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes
Recruiting · NCT06838286 · Observational (researchers observe without assigning treatment) · Lead sponsor: Chong Kun Dang Pharmaceutical
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- Seoul National University Bundang Hospital - Seongnam-si, Gyeonggi-do, South Korea