RecruitingPhase 4NCT06972732

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


Sponsor

Boryung Pharmaceutical Co., Ltd

Enrollment

204 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Inclusion Criteria3

  • Has voluntarily agreed to participate in this clinical trial.
  • Adults over 19 years of age
  • Diagnosed with type 2 diabetes

Exclusion Criteria4

  • Has severe renal and liver disorders
  • Has type 1 diabetes
  • Those who are participating or have participated in other clinical trials and administered their investigational products within 8 weeks before the screening date for this study
  • Those who are deemed ineligible to participate in the study by the investigator

Interventions

DRUGMetformin

The dosage and dose frequency are maintained as they were before the screening.

DRUGDapagliflozin/Pioglitazone

Dapagliflozin 10mg/Pioglitazone 30mg QD

DRUGDapagliflozin/Sitagliptin

Dapagliflozin 10mg/Sitagliptin 100mg QD


Locations(1)

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seocho District, South Korea

View Full Details on ClinicalTrials.gov

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NCT06972732


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