SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes

This study is a randomised, double blinded clinical trial and will be undertaken in primary care and community sites across Australia and tertiary care centres in Sri Lanka. Following a 4-week active run-in period, eligible participants will be randomised to either dapagliflozin 10mg daily, or metformin XR 2000mg daily in a 1:1 ratio.

Inclusion criteria

• Diagnosis of T2D;
• Aged ≥18 years;
• Body mass index > 18.5 kg/m2;
• Drug naïve, or managed with metformin monotherapy and willing to be randomised to either dapagliflozin or metformin;
• eGFR ≥45 ml/min/1,73m2; and
• Signed informed consent.

Exclusion criteria

• Have an immediate need for rapid intensification of glucose lowering therapy due to marked hyperglycaemia; or
• There is a definite indication for, or contraindication to, either metformin or SGLT2 inhibitor; or
• They have clearly documented coronary artery disease (defined as a previous acute coronary syndrome, coronary stent or bypass surgery) or clearly documented heart failure (defined on the basis of a hospital admission, specialist diagnosis or an echocardiogram or other imaging modality); or
• Pregnant or breast-feeding.