This study aims to evaluate the efficacy and safety of initial combination therapy with DWP16001 and DWC202518 compared to DWP16001 monotherapy and DWC202518 monotherapy in patients with Type 2 Diabetes Mellitus
Able and willing to cooperate and participate in this clinical study after understanding the study explanation, and capable of voluntarily signing the written informed consent form before any assessments are performed.
Male or female adult aged ≥18 and ≤80 years. Note: The minimum legal age of adult dependent on local regulations. The legal age of adult in Korea is 19 years, while in Indonesia, it is 18 years.
Have been diagnosed with T2DM based on American Diabetes Association (ADA) guidelines (2025) before screening.
Have an HbA1c ≥7.5% and ≤11% at Visit 1 (Screening) and either have never taken oral anti-diabetic medication since diagnosis or have not taken any oral anti-diabetic medication within 12 weeks prior to screening.
Type 1 diabetes mellitus, congenital diabetes, secondary diabetes, or history of diabetic ketoacidosis, diabetic coma, or precoma
Severe diabetes-related complications, including proliferative diabetic retinopathy, advanced nephropathy, or severe diabetic neuropathy
Clinically significant renal disease, severe gastrointestinal disease or surgery affecting gastrointestinal absorption, pancreatitis, clinically significant urinary/genital infections, dehydration requiring treatment, or uncontrolled thyroid disease
Clinically significant cardiovascular or cerebrovascular disease within 6 months prior to screening, including myocardial infarction, unstable angina, stroke, clinically significant arrhythmia requiring treatment, or New York Heart Association (NYHA) class III-IV heart failure