Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes
NCT ID: NCT06838286
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2024-03-16
2029-12-31
Brief Summary
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Detailed Description
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Participants in this study will have type 2 diabetes mellitus with insufficient glycemic control on conventional combination therapy with a DPP-4i or SGLT2i oral hypoglycemic agent, including metformin, requiring the addition of one of the following: SGLT-2i, DPP-4i, or TZD.
The 3-drug combination therapy will be prescribed to subjects based on the medical judgment of the investigator based on the licensure of SGLT-2i, DPP-4i, or TZD(efficacy, dosing, precautions for use, etc.) in a real-world practice setting and all treatment and observation, including administration of medications and laboratory tests, will be based on the medical judgment of the investigator.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Metformin/DPP4i/SGLT2i
Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs.
SGLT2 inhibitor
SGLT2 inhibitor class of drugs
DPP-4 inhibitor
DPP4 inhibitor class of drugs
Metformin/DPP4i/TZD
Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs.
Thiazolidinedione
Thiazolidinedione class of drugs
DPP-4 inhibitor
DPP4 inhibitor class of drugs
Metformin/SGLT2i/DPP4i
Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs.
SGLT2 inhibitor
SGLT2 inhibitor class of drugs
DPP-4 inhibitor
DPP4 inhibitor class of drugs
Metformin/SGLT2i/TZD
Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs.
SGLT2 inhibitor
SGLT2 inhibitor class of drugs
Thiazolidinedione
Thiazolidinedione class of drugs
Interventions
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SGLT2 inhibitor
SGLT2 inhibitor class of drugs
Thiazolidinedione
Thiazolidinedione class of drugs
DPP-4 inhibitor
DPP4 inhibitor class of drugs
Eligibility Criteria
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Inclusion Criteria
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
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.
19 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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D141_01DM2303
Identifier Type: -
Identifier Source: org_study_id
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