NCT06838286 Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes
| NCT ID | NCT06838286 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chong Kun Dang Pharmaceutical |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2024-03-16 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2024-03-16 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06838286 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06838286 currently recruiting?
Yes, NCT06838286 is actively recruiting participants. Contact the research team at limsoo@snu.ac.kr for enrollment information.
Where is the NCT06838286 trial being conducted?
This trial is being conducted at Seongnam-si, South Korea.
Who is sponsoring the NCT06838286 clinical trial?
NCT06838286 is sponsored by Chong Kun Dang Pharmaceutical. The trial plans to enroll 10,000 participants.
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