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

Recruiting now · Phase 3

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT05345327

Run by

The George Institute

People needed

994

Starts

2023-01-01

Expected to finish

2026-06-30

Last updated by the study team

2024-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kandy National Hospital — Kandy, Sri Lanka (enrolling)
• The George Institute for Global Health — Brisbane, Queensland, Australia (enrolling)
• Monash University — Melbourne, Victoria, Australia (enrolling)
• Jaffna Teaching Hospital — Jaffna, Sri Lanka (enrolling)
• The George Institute for Global Health — Sydney, New South Wales, Australia (enrolling)
• National Hospital of Sri Lanka 1 — Colombo, Sri Lanka (enrolling)
• National Hospital - Galle — Galle, Southern Province, Sri Lanka
• National Hospital of Sri Lanka 2 — Colombo, Sri Lanka

Full record on ClinicalTrials.gov

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