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SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
RECRUITINGPhase 3Sponsored by The George Institute
Actively Recruiting
PhasePhase 3
SponsorThe George Institute
Started2023-01-01
Est. completion2026-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05345327
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
Age: 18 Years+Healthy volunteers accepted
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.
Conditions2
DiabetesType 2 Diabetes
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Actively Recruiting
PhasePhase 3
SponsorThe George Institute
Started2023-01-01
Est. completion2026-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05345327