A Phase IV Clinical Study to Compared the Efficacy and Safety of Switching Metformin+SGLT2-i+DPP4-i to Metformin+SGLT2-i+TZD in Patients With Type 2 Diabetes

Phase 4

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: Metformin; Drug: Dapagliflozin/Pioglitazone; Drug: Dapagliflozin/Sitagliptin

• Registration Number: NCT06972732
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15
• Study Start: 2025-05-30
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 204

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin + Dapagliflozin 10mg/Pioglitazone 30mg	Metformin	One tablet of Metformin and one tablet of Dapagliflozin 10mg/Pioglitazone 30mg administered orally once daily for 24 weeks.
Metformin + Dapagliflozin 10mg/Pioglitazone 30mg	Dapagliflozin/Pioglitazone	One tablet of Metformin and one tablet of Dapagliflozin 10mg/Pioglitazone 30mg administered orally once daily for 24 weeks.
Metformin + Dapagliflozin 10mg/Sitagliptin 100mg	Metformin	One tablet of Metformin and one tablet of Dapagliflozin 10mg/Sitagliptin 100mg administered orally once daily for 24 weeks.
Metformin + Dapagliflozin 10mg/Sitagliptin 100mg	Dapagliflozin/Sitagliptin	One tablet of Metformin and one tablet of Dapagliflozin 10mg/Sitagliptin 100mg administered orally once daily for 24 weeks.

Primary Outcome Measures

Name	Time	Method
HbA1c (%) change at 24 weeks compared to the baseline (Visit 2)	From baseline to end of treatment at 24 weeks	The mean change of HbA1c at 24 weeks compared to the baseline (Visit 2) is evaluated.

Trial Locations

Locations (1)

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Seocho District, Korea, Republic of