A study to evaluate the effect of dapagliflozin on blood glucose level and renal safety in patients with Type 2 Diabetes - DERIVE

Exclusion Criteria

• - Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
• - History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
• - Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or Diastolic Blood Pressure (DBP) ≥110 mmHg
• - Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to signing the consent at visit 1:
• Myocardial infarction, Cardiac surgery or revascularization(CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia.
• - History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.
• - Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
• - Ongoing treatment with any SGLT2-inhibitor, GLP-1 analogue, or rapid/short acting insulins at screening.
• - Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at visit 1.