Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes (TRIO)

Chong Kun Dang

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: SGLT2 inhibitor; Drug: DPP-4 inhibitor; Drug: Thiazolidinedione

Study type: Observational

Funder types: Industry

Identifiers

NCT06838286

D141_01DM2303

Details and patient eligibility

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

10,000 participants in 4 patient groups

Metformin/DPP4i/SGLT2i

Description:

Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs.

Treatment:

Drug: DPP-4 inhibitor

Drug: SGLT2 inhibitor

Metformin/DPP4i/TZD

Description:

Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs.

Treatment:

Drug: Thiazolidinedione

Drug: DPP-4 inhibitor

Metformin/SGLT2i/DPP4i

Description:

Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs.

Treatment:

Drug: DPP-4 inhibitor

Drug: SGLT2 inhibitor

Metformin/SGLT2i/TZD

Description:

Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs.

Treatment:

Drug: Thiazolidinedione

Drug: SGLT2 inhibitor