RecruitingRecruiting
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
NCT06972732 · Boryung Pharmaceutical Co., Ltd
In plain English
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Official title
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
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.
Eligibility criteria
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 design
Enrollment target: 204 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-06-11
Estimated completion: 2026-10-01
Last updated: 2025-09-15
Interventions
Drug: MetforminDrug: Dapagliflozin/PioglitazoneDrug: Dapagliflozin/Sitagliptin
Primary outcomes
- • HbA1c (%) change at 24 weeks compared to the baseline (Visit 2) (From baseline to end of treatment at 24 weeks)
Sponsor
Boryung Pharmaceutical Co., Ltd · industry
Contacts & investigators
ContactOh · contact · syoh@boryung.co.kr · +82 2-708-8000
All locations (1)
The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
Seoul, Seocho District, South Korea