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Recruiting Phase 3 NCT05345327

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

Trial Parameters

Condition Type 2 Diabetes
Sponsor The George Institute
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 994
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-01-01
Completion 2026-06-30
Interventions
DapagliflozinMetformin

Brief 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 Type 2 Diabetes.

Eligibility Criteria

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.

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