NCT06972732

A Phase IV Clinical Trial to Compare the Efficacy and Safety of Metformin+Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2-i)+Thiazolidinedione (TZD) in Patients With Type 2 Diabetes

A Randomized, Open-label, Active-controlled, Parallel, Multicenter, Phase IV Clinical Trial to Compare the Efficacy and Safety of Switching Metformin+SGLT2-i+Dipeptidyl Peptidase-4-inhibitor(DPP-4-i) to Metformin+SGLT2-i+TZD in Patients With Type 2 Diabetes

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, active-controlled, parallel, multicenter, phase IV clinical study evaluating the efficacy and safety of switching Metformin+SGLT2-i+DPP4-i to Metformin+SGLT2-i+TZD in patients with type 2 diabetes.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Metformin	The dosage and dose frequency are maintained as they were before the screening.
DRUG	Dapagliflozin/Pioglitazone	Dapagliflozin 10mg/Pioglitazone 30mg QD
DRUG	Dapagliflozin/Sitagliptin	Dapagliflozin 10mg/Sitagliptin 100mg QD

Timeline

• Start date: 2025-06-11
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-05-15
• Last updated: 2025-09-15

Locations

1 site across 1 country: South Korea