The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin

Inclusion Criteria: 1. Subjects with T2DM aged 18 to 80 years 2. Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5% 3. Subjects with BMI of 20-45 kg/m2 4. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study Exclusion Criteria: 1. Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors) 2. Diabetic ketoacidosis, diabetic coma or precoma within the past year 3. Urinary tract infections or genital infections within 4. Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 110 mmHg) 5. eGFR \< 60 mL/min/1.73 m2 6. Severe heart failure (NYHA class III/IV)