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

Phase 4RecruitingNCT06972732

Boryung Pharmaceutical Co., Ltd204 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

204

Conditions

Type 2 Diabetes

Interventions

MetforminDRUG

The dosage and dose frequency are maintained as they were before the screening.

Dapagliflozin/PioglitazoneDRUG

Dapagliflozin 10mg/Pioglitazone 30mg QD

Dapagliflozin/SitagliptinDRUG

Dapagliflozin 10mg/Sitagliptin 100mg QD

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seocho District, South Korea

RECRUITING

Outcomes

Primary Outcomes

HbA1c (%) change at 24 weeks compared to the baseline (Visit 2)

The mean change of HbA1c at 24 weeks compared to the baseline (Visit 2) is evaluated.

Time frame: From baseline to end of treatment at 24 weeks

Central Contacts

CONTACT

+82 2-708-8000 syoh@boryung.co.kr

Data from ClinicalTrials.gov

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