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

Sponsor
Boryung Pharmaceutical Co., Ltd
Study ID
NCT06972732
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 11, 2025
Status verified
Sep 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin + Dapagliflozin 10mg/Pioglitazone 30mg
    One tablet of Metformin and one tablet of Dapagliflozin 10mg/Pioglitazone 30mg administered orally once daily for 24 weeks.
  • Active Comparator: Metformin + Dapagliflozin 10mg/Sitagliptin 100mg
    One tablet of Metformin and one tablet of Dapagliflozin 10mg/Sitagliptin 100mg administered orally once daily for 24 weeks.

Primary Outcome Measure

HbA1c (%) change at 24 weeks compared to the baseline (Visit 2) [ Time Frame: From baseline to end of treatment at 24 weeks ]

Central Contacts

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