SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
Recruiting · NCT05345327 · Interventional (participants receive a specific treatment) · Lead sponsor: The George Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
8 locations listed.
- National Hospital of Sri Lanka 1 - Colombo, Sri Lanka
- National Hospital of Sri Lanka 2 - Colombo, Sri Lanka
- Jaffna Teaching Hospital - Jaffna, Sri Lanka
- Kandy National Hospital - Kandy, Sri Lanka
- The George Institute for Global Health - Sydney, New South Wales, Australia
- The George Institute for Global Health - Brisbane, Queensland, Australia
- National Hospital - Galle - Galle, Southern Province, Sri Lanka
- Monash University - Melbourne, Victoria, Australia