None listed
Conditions
Interventions
Drug : This study targets patients with type 2 diabetes who have been treated for at least 8 weeks with a DPP4 inhibitor alone, or in combination with metformin and/or a sulfonylurea, but have not ach
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Adults aged 19 to 75 years at the time of providing written informed consent. 2)Diagnosed with type 2 diabetes mellitus, with HbA1c levels between 7.5% and 11.0%. 3)Has been treated with a DPP4 inhibitor alone, or in dual or triple combination therapy with metformin and/or a sulfonylurea, without any dose changes for at least 8 weeks prior to screening. 4)Has voluntarily provided written informed consent after receiving a full explanation of the clinical trial. 5)Is able to understand the study procedures, is cooperative, and is expected to participate until the end of the study.
Exclusion criteria
Exclusion criteria: 1.Patients with diabetes other than type 2 diabetes, including type 1 diabetes and gestational diabetes. 2.Patients who have taken TZD or SGLT2 inhibitors within the past 8 weeks, or who discontinued these drugs due to serious adverse effects. 3.Patients currently being treated with four or more antidiabetic medications. 4.Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis (with or without coma), or a history of ketoacidosis within the past 24 weeks. 5.Patients with known allergy or hypersensitivity to the investigational drugs or any of their components. 6.Patients who have received chronic corticosteroid therapy (oral or non-oral) for more than 14 consecutive days within 8 weeks prior to screening, and require ongoing dose adjustments for therapeutic purposes. 7.Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 8.Patients currently undergoing treatment for malignant tumors or with progressive cancer. 9.Patients with a history of drug or alcohol abuse within the past 12 weeks. 10.Patients infected with human immunodeficiency virus (HIV). 11.Patients with severe infections, pre/post-surgical conditions, or severe trauma. 12.Patients with a history of heart failure (NYHA Class III–IV) within the past 24 weeks. 13.Patients with acute cardiovascular disease within the past 12 weeks, including unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass grafting, or coronary intervention. 14.Patients with renal failure or chronic kidney disease (estimated glomerular filtration rate < 25 mL/min/1.73m²), or those undergoing dialysis, making use of the investigational drugs inappropriate. 15.Patients with active bladder cancer or a history of bladder cancer. 16.Patients with abnormal liver function, defined as serum levels of ALT, AST, or ALP exceeding 5 times the upper limit of normal (ULN), or total bilirubin exceeding 5 times the ULN. 17.Pregnant or breastfeeding women. 18.Patients who have received other investigational drugs within the past 12 weeks or are currently participating in another clinical trial (except for observational or retrospective studies deemed by the investigator not to affect the efficacy or safety of this trial). 19.Patients deemed by the investigator to be unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycemic Parameters- Fasting (0 min) / Postprandial (60 min) Glucose, C-peptide, Insulin;Lipid Profile Parameters- Total cholesterol, triglyceride, HDL-C, LDL-C;Body composition markers assessed by InBody analysis, including muscle mass, visceral fat area, and subcutaneous fat area;Markers of Insulin Resistance and Secretion Capacity- HOMA-IR, HOMA-beta, Insulinogenic Index | — |
Countries
Korea, Republic of
Contacts
Public ContactBongsoo Cha
Yonsei University Health System, Severance Hospital
Outcome results
None listed