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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin, Dapagliflozin/Pioglitazone, Dapagliflozin/Sitagliptin.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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.
Interventions
- Drug Metformin
The dosage and dose frequency are maintained as they were before the screening. - Drug Dapagliflozin/Pioglitazone
Dapagliflozin 10mg/Pioglitazone 30mg QD - Drug Dapagliflozin/Sitagliptin
Dapagliflozin 10mg/Sitagliptin 100mg QD
Primary outcome measures
- HbA1c (%) change at 24 weeks compared to the baseline (Visit 2) [Time frame: From baseline to end of treatment at 24 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul
Identifiers
NCT: NCT06972732 · BR-DPC-CT-401