Recruiting
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
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.
ClinicalTrials.gov IDNCT06972732
PhasePHASE4
Enrollment204
SponsorBoryung Pharmaceutical Co., Ltd
Age19 Years
SexALL
Conditions studied
Type 2 Diabetes
About this study
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.
Interventions
- 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
Primary outcomes
- HbA1c (%) change at 24 weeks compared to the baseline (Visit 2) (From baseline to end of treatment at 24 weeks)
Eligibility information
Inclusion Criteria:
* Has voluntarily agreed to participate in this clinical trial.
* Adults over 19 years of age
* Diagnosed with type 2 diabetes
Exclusion Criteria:
* 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
Study locations
- The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Seocho District 06591 South Korea
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.