NCT05345327RecruitingPhase 3
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 20 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 994 (estimated)
- First submitted
- 19 Apr 2022
- Start date
- 1 Jan 2023
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- The George Institute
- Diseases
- Type 2 diabetes
- NCT number
- NCT05345327
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 994
- From 1 Jan 2023 to the primary completion date, 30 Jun 2026
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Lab values
- Have an immediate need for rapid intensification of glucose lowering therapy due to marked hyperglycaemia; or
Other
- Pregnant or breast-feeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The George Institute for Global Health Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Monash University Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| The George Institute for Global Health Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| National Hospital of Sri Lanka 1 Coordinator of this site? Confirm its status | Colombo | Sri Lanka | Recruiting |
| National Hospital of Sri Lanka 2 Coordinator of this site? Confirm its status | Colombo | Sri Lanka | Not yet recruiting |
| National Hospital Galle Coordinator of this site? Confirm its status | Galle | Sri Lanka | Not yet recruiting |
| Jaffna Teaching Hospital Coordinator of this site? Confirm its status | Jaffna | Sri Lanka | Recruiting |
| Kandy National Hospital Coordinator of this site? Confirm its status | Kandy | Sri Lanka | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.