SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe George Institute
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Dapagliflozin
- Metformin
Treatment groups
994 Participants
are divided into 2 treatment groupsSponsors and collaborators
The George Institute
Lead sponsor
The University of New South Wales
Collaborator
Monash University
Collaborator
University of Sydney
Collaborator
Source ClinicalTrials.gov