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

• Status: Not yet recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the trial is to evaluate the effects of the SGLT2 inhibitor, dapagliflozin, compared to metformin on annual decline in eGFR when used as first line therapy in people with recently diagnosed Type 2 Diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The George Institute
• Collaborators: Monash University; The University of New South Wales; University of Sydney
• Treatments: Dapagliflozin; Metformin

Criteria

Inclusion Criteria:

• Diagnosis of T2D within the last 4 years;

• Aged ≥18 years;

• Body mass index between 18.5 and 45 kg/m2;

• Drug naïve, or managed with metformin monotherapy and willing to be randomised to either dapagliflozin or metformin;

• eGFR ≥30 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.