NCT06838286

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

A Multicenter, Prospective, Non-interventional Observation Study to Evaluate the Safety and Effectiveness of OAD Triple Therapy in Korean Type 2 Diabetic Mellitus Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	SGLT2 inhibitor	SGLT2 inhibitor class of drugs
DRUG	Thiazolidinedione	Thiazolidinedione class of drugs
DRUG	DPP-4 inhibitor	DPP4 inhibitor class of drugs

Timeline

• Start date: 2024-03-16
• Primary completion: 2026-12-31
• Completion: 2029-12-31
• First posted: 2025-02-20
• Last updated: 2025-02-20

Locations

1 site across 1 country: South Korea