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SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes

NCT05345327 · The George Institute
In plain English

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About this study
This study is a randomised, double blinded clinical trial and will be undertaken in primary care and community sites across Australia and tertiary care centres in Sri Lanka. Following a 4-week active run-in period, eligible participants will be randomised to either dapagliflozin 10mg daily, or metformin XR 2000mg daily in a 1:1 ratio.
Eligibility criteria
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.
Study design
Enrollment target: 994 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-01-01
Estimated completion: 2026-06-30
Last updated: 2024-12-20
Interventions
Drug: DapagliflozinDrug: Metformin
Primary outcomes
  • Rate of decline in eGFR (24 months)
Sponsor
The George Institute · other
With: The University of New South Wales, Monash University, University of Sydney
Contacts & investigators
ContactEmma Zhang · contact · ezhang1@georgeinstitute.org.au · +61 2 8052 4337
ContactSarah Stanton · contact · sstanton@georgeinstitute.org.au
InvestigatorBruce Neal · study_chair, The George Institute for Global Health (Sydney, Australia)
InvestigatorClare Arnott · study_chair, The George Institute for Global Health (Sydney, Australia)
All locations (8)
The George Institute for Global HealthRecruiting
Sydney, New South Wales, Australia
The George Institute for Global HealthRecruiting
Brisbane, Queensland, Australia
Monash UniversityRecruiting
Melbourne, Victoria, Australia
National Hospital - GalleNot Yet Recruiting
Galle, Southern Province, Sri Lanka
National Hospital of Sri Lanka 1Recruiting
Colombo, Sri Lanka
National Hospital of Sri Lanka 2Not Yet Recruiting
Colombo, Sri Lanka
Jaffna Teaching HospitalRecruiting
Jaffna, Sri Lanka
Kandy National HospitalRecruiting
Kandy, Sri Lanka
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes · TrialPath