A Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or 30mg Add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin

Exclusion Criteria

• •1. Uncontrolled hyperglycemia at Visit 1 or Visit 2 (subjects with FPG \> 270 mg/dL as a result of the test conducted by the study institution.)
• •2. Medication compliance is \<70% or \>120% for each BR3003D, BR3003C, BR3003A-2, and BR3003B-2 during the Run-in period at Visit 2.
• •3. Patients with other types of diabetes instead of type 2 diabetes (e.g., type 1 diabetes, secondary diabetes, or congenital renal glycosuria).
• •4. Patients with uncontrolled, severe diabetic complications (e.g., proliferative diabetic retinopathy uncontrolled despite medication and severe diabetic neuropathy)
• •5. Those who suffered from acute or chronic metabolic acidosis within 3 months as of Visit 1, including lactic acidosis and diabetic ketoacidosis.
• •6. Those with \> 40 kg/m2 of BMI measured at Visit 1.
• •7. Those with uncontrolled hypertension at Visit 1 or Visit 2 (SBP \> 180 mmHg or DBP \> 110 mmHg).
• •8. Those diagnosed with cardiovascular diseases (myocardial infarction, stroke, unstable angina, and transient ischemic attack (TIA)) or undergo revascularization within 3 months as of Visit 1
• •9. Those with heart failure (NYHA class II\~IV) or who had suffered from heart failure.
• •10. Those who suffered from gastrointestinal diseases that may affect the absorption, distribution, metabolism, and excretion of investigational products or had underwent surgery;
• •11. Those who underwent surgery requiring general anesthesia within 4 weeks as of Visit 1 or who are scheduled to receive such surgery within 4 weeks after the study ends
• •12. Those with a history of malignant tumor within 5 years as of Visit 1
• •13. Those who have a clinically significant liver disease
• •14. Those who have a clinically significant renal disease
• •15. Those with clinically significant hematuria detected at Visit 1 or Visit 2
• •16. Those with chronic diseases requiring the continued use of systemic steroid or immunosuppressants (oral administration, injection, or inhalation).
• •17. Patients with pituitary insufficiency or adrenal insufficiency.
• •18. Those with clinically significant severe infection or trauma based on an investigator's judgement.
• •19. Patients with AIDS.
• •20. Patients with acute or chronic diseases that may cause histotoxic hypoxia such as respiratory failure and shock.
• •21. Those who need treatment due to dehydration caused by persistent diarrhea and vomiting or at a risk of fluid volume depletion.
• •22. Those who have been administered with the following drugs or expected to require the continued administration during the study period:
• •* Those administered with systemic steroid agents (Prednisolone, \>30 mg/day) within 2 weeks as of Visit 1.
• •* Those being administered with thyroid medications and whose dose has been modified within 6 weeks as of Visit 1 (however, dose reduction is accepted.)
• •* Those being administered with diuretics and whose dose has been modified within 8 weeks as of Visit 1 however, dose reduction is accepted.)
• •* Those who have been administered with antidiabetics other than Metformin and Dapagliflozin within 8 weeks as of Visit 1.
• •* Those who have been administered with obesity drugs (e.g., phentermine, phendimetrazine, diethylpropion, and mazindol) within 12 weeks as of Visit 1.
• •* Those who need to take prohibited concomitant medications stated here during the study period.
• •23. Those with history of alcohol or drug abuse within 1 year as of Visit 1.
• •24. Those who had allergic reaction to main ingredients or components of the investigational products.
• •25. Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
• •26. Females who are pregnant or breastfeeding.
• •27. Patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method
• •28. Those who are currently participating in other ongoing clinical studies or those who have taken the investigational products from other clinical studies within 12 weeks as of Visit 1
• •29. Those who are judged unsuitable for the study by a principal investigator or investigators.