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

• Percent change from baseline in total body weight at Week 24. [ Time Frame: At Week 24 ]
  To compare the percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.
• Change from baseline in FPG at Week 24. [ Time Frame: At Week 24 ]
  To compare the change from baseline in FPG between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.
• Change from baseline in seated SBP at Week 24. [ Time Frame: At Week 24 ]
  To compare the change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.

• Drug: Dapagliflozin 10 mg
  Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy
  Other Name: Farxiga™
• Drug: Matching Placebo for Dapagliflozin
  Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks

• Experimental: Dapagliflozin
  10 mg Tablets, Oral, Once daily, 24 weeks
  Intervention: Drug: Dapagliflozin 10 mg
• Placebo Comparator: Placebo
  Matching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks
  Intervention: Drug: Matching Placebo for Dapagliflozin

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.