RECRUITINGPhase 3INTERVENTIONAL
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Dapagliflozin
SGLT2 inhibitor
DRUG
Metformin
Metformin
Locations (8)
The George Institute for Global Health
Sydney, New South Wales, Australia
The George Institute for Global Health
Brisbane, Queensland, Australia
Monash University
Melbourne, Victoria, Australia
National Hospital - Galle
Galle, Southern Province, Sri Lanka
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