Phase 3 study for people with Type 2 Diabetes

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor The George Institute
Registry number NCT05345327
Started 1 January 2023 Today 16 October 2026 Estimated completion 30 June 2026

Past estimated completion. The registry still lists this trial as open, and the date it gave for finishing has been and gone. Confirm with the official record before you act on it.

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
The George Institute for Global Health Sydney NSW Recruiting
The George Institute for Global Health Brisbane QLD Recruiting
Monash University Melbourne VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 994

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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.

Dates on the record

Started 1 January 2023
Estimated completion 30 June 2026
Registry last updated 20 December 2024
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 20 December 2024.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.