Actively Recruiting
A Randomized, Open-label, Active-controlled, Parallel, Multicenter Phase IV Trial Comparing the Efficacy and Safety of Switching Metformin+SGLT2-i+DPP4-i to Metformin+SGLT2-i+TZD in Type 2 Diabetes
Led by Boryung Pharmaceutical Co., Ltd · Updated on 2025-09-15
204
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of switching treatment combinations in adults with type 2 diabetes. This phase IV, randomized, open-label, active-controlled, parallel, multicenter study compares the safety and efficacy of changing from Metformin plus SGLT2 inhibitor and DPP4 inhibitor to Metformin plus SGLT2 inhibitor and Thiazolidinedione (TZD). This study helps understand how different drug combinations work for managing type 2 diabetes and is sponsored by Boryung Pharmaceutical Co., Ltd. Participants will receive one of two treatments orally once daily for 24 weeks. One group takes Metformin with Dapagliflozin 10 mg and Pioglitazone 30 mg, while the other group takes Metformin with Dapagliflozin 10 mg and Sitagliptin 100 mg. The Metformin dose and schedule remain the same as before screening. Both treatments last for 24 weeks under this study protocol. During the study, researchers will measure changes in HbA1c levels from the start to the end of the 24 weeks to assess blood sugar control. Participants will be monitored regularly to evaluate safety and treatment effects. The total participation time covers the 24-week treatment period, during which participants will have study visits and assessments to track their progress and any side effects.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has voluntarily agreed to participate in this clinical trial.
- Adults over 19 years of age
- Diagnosed with type 2 diabetes
You will not qualify if you...
- Has severe renal and liver disorders
- Has type 1 diabetes
- Participated in other clinical trials with investigational products within 8 weeks before screening
- Deemed ineligible to participate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive one tablet of Metformin and one tablet of either Dapagliflozin 10mg/Pioglitazone 30mg or Dapagliflozin 10mg/Sitagliptin 100mg orally once daily.
Visits occur at baseline and periodically during the 24-week treatment period
Trial Site Locations
Total: 1 location
1
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seocho District, South Korea, 06591
Actively Recruiting
Research Team
O
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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