Using SGLT2 inhibitors to prevent kidney decline in Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of dapagliflozin, an SGLT2 inhibitor, compared to metformin in preventing renal decline in patients with Type 2 Diabetes. It is a randomized, double-blinded study conducted in primary care and community sites across Australia and tertiary care centers in Sri Lanka. Participants will undergo a 4-week run-in period before being assigned to either dapagliflozin or metformin in a 1:1 ratio. The primary outcome is the annual decline in estimated glomerular filtration rate (eGFR).

Why it matters

Who can join: the full rules

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.

Where it's running

• The George Institute for Global Health
  Sydney, New South Wales, Australia Recruiting
• The George Institute for Global Health
  Brisbane, Queensland, Australia Recruiting
• Monash University
  Melbourne, Victoria, Australia Recruiting
• National Hospital of Sri Lanka 1
  Colombo, Sri Lanka Recruiting
• Jaffna Teaching Hospital
  Jaffna, Sri Lanka Recruiting
• Kandy National Hospital
  Kandy, Sri Lanka Recruiting

Study contacts

• Study coordinator: Emma Zhang
• Email: ezhang1@georgeinstitute.org.au
• Phone: +61 2 8052 4337

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.