NCT05345327 SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
| NCT ID | NCT05345327 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The George Institute |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 994 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 994 participants in total. It began in 2023-01-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Bruce Neal
STUDY CHAIR
The George Institute for Global Health (Sydney, Australia)
Frequently Asked Questions
Who can join the NCT05345327 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05345327 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 994 participants.
Is NCT05345327 currently recruiting?
Yes, NCT05345327 is actively recruiting participants. Contact the research team at ezhang1@georgeinstitute.org.au for enrollment information.
Where is the NCT05345327 trial being conducted?
This trial is being conducted at Sydney, Australia, Brisbane, Australia, Melbourne, Australia, Galle, Sri Lanka and 4 additional locations.
Who is sponsoring the NCT05345327 clinical trial?
NCT05345327 is sponsored by The George Institute. The principal investigator is Bruce Neal at The George Institute for Global Health (Sydney, Australia). The trial plans to enroll 994 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.