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NCT06838286 | RECRUITING | Diabetes Mellitus, Type 2

Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes
Sponsor:

Chong Kun Dang Pharmaceutical

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.

Condition or disease

Diabetes Mellitus, Type 2

Intervention/treatment

SGLT2 inhibitor

Thiazolidinedione

DPP-4 inhibitor

Detailed Description:

The study was designed as a multicenter, prospective, non-interventional, observational study in patients with type 2 diabetes mellitus who had inadequate glycemic control with conventional combination oral hypoglycemic agents including metformin. 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 10000 participants
Official Title : A Multicenter, Prospective, Non-interventional Observation Study to Evaluate the Safety and Effectiveness of OAD Triple Therapy in Korean Type 2 Diabetic Mellitus Patients
Actual Study Start Date : 2024-03-16
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2029-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes

Location Details

NCT06838286

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How to Participate

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Locations

RECRUITING

South Korea, Gyeonggi-do

Seoul National University Bundang Hospital

Seongnam-shi, Gyeonggi-do, South Korea,