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

Inclusion criteria

• Those who voluntarily signed the informed consent to participate in this study.
• Adults aged 19 years or older.
• Those diagnosed with type 2 diabetes mellitus.
• Subjects taking constant doses of ≥1000mg of Metformin and 10 mg of Dapagliflozin for more than 8 weeks at Visit 1 (regardless of dosage forms (immediate-release and sustained-release) and single agent or combination drug.)
• Subjects with 7% ≤ HbA1c ≤ 10.5% at Visit 1 and Visit 2
• Subjects able to understand the study, comply with study procedures, and attend all scheduled visits.

Exclusion criteria

• 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.)
• Medication compliance is <70% or >120% for each BR3003D, BR3003C, BR3003A-2, and BR3003B-2 during the Run-in period at Visit 2.
• Patients with other types of diabetes instead of type 2 diabetes (e.g., type 1 diabetes, secondary diabetes, or congenital renal glycosuria).
• Patients with uncontrolled, severe diabetic complications (e.g., proliferative diabetic retinopathy uncontrolled despite medication and severe diabetic neuropathy)
• Those who suffered from acute or chronic metabolic acidosis within 3 months as of Visit 1, including lactic acidosis and diabetic ketoacidosis.
• Those with > 40 kg/m2 of BMI measured at Visit 1.
• Those with uncontrolled hypertension at Visit 1 or Visit 2 (SBP > 180 mmHg or DBP > 110 mmHg).
• 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
• Those with heart failure (NYHA class II~IV) or who had suffered from heart failure.
• Those who suffered from gastrointestinal diseases that may affect the absorption, distribution, metabolism, and excretion of investigational products or had underwent surgery;
• 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
• Those with a history of malignant tumor within 5 years as of Visit 1
• Those who have a clinically significant liver disease
• Those who have a clinically significant renal disease
• Those with clinically significant hematuria detected at Visit 1 or Visit 2
• Those with chronic diseases requiring the continued use of systemic steroid or immunosuppressants (oral administration, injection, or inhalation).
• Patients with pituitary insufficiency or adrenal insufficiency.
• Those with clinically significant severe infection or trauma based on an investigator's judgement.
• Patients with AIDS.
• Patients with acute or chronic diseases that may cause histotoxic hypoxia such as respiratory failure and shock.
• Those who need treatment due to dehydration caused by persistent diarrhea and vomiting or at a risk of fluid volume depletion.
• 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.
• Those with history of alcohol or drug abuse within 1 year as of Visit 1.
• Those who had allergic reaction to main ingredients or components of the investigational products.
• Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
• Females who are pregnant or breastfeeding.
• Patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method
• 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
• Those who are judged unsuitable for the study by a principal investigator or investigators.