A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes

Inclusion Criteria:

- Female or male aged ≥18 years and <75 years.

- History of T2DM for more than 12 months.

- Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11%

- Stable anti-diabetic treatment regimen

- Renal impairment: CKD 3A

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.