Using SGLT2 inhibitors to prevent kidney decline in Type 2 Diabetes
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
This study is testing whether a new diabetes medication called dapagliflozin can better prevent kidney problems compared to the standard treatment metformin for people with Type 2 Diabetes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 994 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The George Institute Academic / other |
| Locations | 8 sites (Sydney, New South Wales and 7 other locations) |
| Trial ID | NCT05345327 on ClinicalTrials.gov |
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).
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of Type 2 Diabetes who are either drug-naïve or currently managed with metformin monotherapy.
Not a fit: Patients with an immediate need for rapid glucose lowering therapy or those with documented coronary artery disease or heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new first-line treatment option that better preserves kidney function in patients with Type 2 Diabetes.
How similar studies have performed: Other studies have shown promising results with SGLT2 inhibitors in managing renal outcomes in diabetes, indicating that this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sydney, New South Wales and 7 other locations
- 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 - Galle — Galle, Southern Province, Sri Lanka (Not_yet_recruiting)
- National Hospital of Sri Lanka 1 — Colombo, Sri Lanka (Recruiting)
- National Hospital of Sri Lanka 2 — Colombo, Sri Lanka (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.